Visitors to booth #3C88 will find the ‘The Longevity Shift’—the company’s highly acclaimed interactive installation making its European debut at the show. Designed to spark a fundamental reframing of how the industry thinks about longevity, the experience highlights the nutrition industry’s need to shift from life expectancy to health expectancy and focuses on science-backed approaches to support health in later life and ensure that later years are some of the best.

The company will spotlight two new innovations from its health expectancy portfolio. Featured at booth #3C88 and in the New Products Zone, Age Slower targets chronic inflammation—one of the key hallmarks of aging—and is supported by landmark DO-HEALTH trial research demonstrating that life’s®OMEGA 60 and Quali®-D combined can slow biological aging by approximately three months over three years. Its second innovation—Cellular Repair—targets cellular senescence. It features natural flavonoids with senolytic properties that selectively eliminate senescent “zombie” cells without harming healthy ones. Cellular Repair will be available for visitors to sample in an innovative on-the-go format using the ‘Easy Snap’ one-hand opening technology at the Tasting Centre. 

“The science we’re presenting at Vitafoods Europe 2026—from slowing biological aging to targeting the hallmarks of aging—represents a genuine leap forward for the category, and we want attendees to experience what that means in practice in our immersive experience. Our ambition is to lead the longevity category globally, and Barcelona is where we’re going to continue building on our global position within Europe,” commented Giovanni Calderoni, VP of Dietary Supplements EMEA at dsm-firmenich. To learn more and book a meeting with the dsm-firmenich team at Vitafoods Europe 2026, visit the event page.

Why this matters for industry

MMPs are moving quickly from frontier science to real pipelines, but the concept paper explicitly recognizes a core bottleneck: today there is no tailored regulatory framework for non-clinical evaluation of MMPs, and existing guidelines were largely built for standard pharmaceuticals (including biologics) and ATMPs. According to EMA, this mismatch creates uncertainty for developers, inconsistencies in submissions and assessments, and can translate into development delays. 

For companies, the message is straightforward: regulators are preparing a more structured “playbook” for the non-clinical package, and early alignment will be a competitive advantage—especially for programs approaching first-in-human studies or pivotal clinical development.

What EMA includes (and excludes) under “microbiome-based medicinal products”

EMA frames MMPs as therapeutics originating from microbiomes (human, food-related and/or environmental) designed to treat or prevent disease by modulating the human microbiome. These products may consist of live or non-living microorganisms or their derivatives, with effects dependent on the strain(s) and site of administration—factors that add complexity to non-clinical development. 

The scope covers an illustrative set of product types, including Live Biotherapeutic Products, whole/highly complex ecosystem-based products, certain non-ATMP SoHO-derived medicinal products, and non-living MMPs (e.g., inanimate cells). 

Equally important is what is out of scope:

• Human Microbiota Transplantation (as a procedure) under the SoHO Regulation (EU) 2024/1938
• MMPs with genetically modified microorganisms classified as ATMPs
• Food supplements and fermented-food cultures (not intended to prevent/treat disease)
• Vaccines/standard immunological products not acting via microbiome modulation
• Phage therapy/virome-based approaches, acknowledged as potentially relevant but likely for separate future work 

The key scientific/regulatory pain points EMA wants to tackle

The proposed reflection paper is meant to address aspects where conventional paradigms often break down for MMPs, notably: 

1. Product diversity. From fixed compositions to tailored microbial consortia, with potentially different non-clinical strategies depending on the product type.
2. Target diversity. MMPs may target any human-associated microbiome—gut, skin, oral, respiratory, urogenital, nasal, and beyond—so a one-size-fits-all approach is unlikely.
3. Pharmacology models and dose selection. EMA highlights the limits of standard animal disease models, which may have poor relevance due to species-specific microbiome effects and limited translatability. The concept paper explicitly points to alternative models and New Approach Methodologies (NAMs) as potentially important. 
4. Safety and biodistribution. Traditional toxicity approaches may not be appropriate. EMA calls out specific concerns that repeatedly surface for microbiome-based therapies:
   1. Biodistribution, including potential translocation
   2. Persistence
   3. Degradation/elimination pathways
   4. Potential shedding 

Timing and process: the consultation window is open now

The concept paper was adopted by CHMP for release for consultation on 16 February 2026, with a public consultation running from 2 March 2026 to 30 April 2026. EMA notes that comments received will be considered when preparing the draft reflection paper. 

The work will involve multiple EMA groups, including the Non-Clinical Working Party (NcWP) and others spanning quality, classification/borderline issues and clinical trial coordination. 

Expected impact (and what it signals to the market)

• EMA anticipates that the reflection paper will:
• Enhance regulatory clarity
• Promote EU harmonization
• Reduce unnecessary animal use in pharmacology/safety packages
• Reduce uncertainty and delays
• Support flexible, science-based approaches
• Improve patient safety through more rigorous evaluation of novel MMPs 

For companies and investors, this is also a signal: EMA is treating MMPs as a strategic, fast-evolving class where regulatory science needs to catch up—an environment in which well-designed development packages and early regulator engagement can materially de-risk programs.

What companies should do now (practical takeaways)

• Map your non-clinical package to the four focus areas EMA lists (product diversity, target diversity, models/NAMs, safety/biodistribution/shedding) and identify gaps early. 
• Prepare to justify model relevance: if animal models are used, be ready to defend translatability; if NAMs are used, document validity and decision impact. 
• Pressure-test your safety narrative around persistence, translocation and shedding—topics likely to become “standard questions” across dossiers. 
• Engage in the consultation: EMA explicitly invites the pharmaceutical industry, academia, national authorities, EU agencies (ECDC, EDQM, EFSA), patient groups and healthcare professionals to contribute. Submitting comments is an opportunity to ensure the eventual reflection paper is workable for real-world development. 

MaaT Pharma, based in Lyon and listed on Euronext Paris, unveiled the final results of its ARES Phase 3 trial of Xervyteg® (MaaT013), a pooled-donor microbiome ecosystem therapy delivered by enema. The drug was tested as a third-line treatment in adult patients with severe, gastrointestinal acute graft-versus-host disease (GI-aGvHD) who had already failed both systemic corticosteroids and ruxolitinib. This is the part of the treatment pathway where options run out and survival curves typically fall off a cliff.

In ARES, 1-year overall survival reached 54%, and median overall survival was not reached at the time of analysis, meaning more than half of the patients were still alive at 12 months. For this population, that is a striking number rather than just another incremental gain. 

Why these patients are so hard to treat

Acute graft-versus-host disease is a well-known and feared complication of allogeneic stem cell or bone marrow transplantation. Within about 100 days of the transplant, the donor immune cells can begin to attack the recipient’s tissues, inflaming skin, liver, and—most devastatingly—the gastrointestinal tract. When the gut is involved, patients can experience massive diarrhea, abdominal pain, bleeding, infections, malnutrition, and organ failure. Mortality climbs fast, especially in those with severe GI disease. 

Standard first-line therapy is systemic steroids. Patients who don’t respond are considered steroid-refractory and move to second-line agents. Over the past few years, ruxolitinib, a JAK1/2 inhibitor, has become the reference second-line therapy for steroid-refractory aGvHD based on the REACH studies and regulatory approvals in both the US and Europe. 

Even so, survival remains disappointing for patients who fail both steroids and ruxolitinib. In pediatrics, a mesenchymal stromal cell product, remestemcel-L, was approved in the US in 2024 as a second-line option, but there is still no well-established third-line standard, and for adults, choices are a patchwork of off-label immunosuppressants, clinical trials, or best supportive care. In that context, the ARES data are not just another dataset; they test whether reshaping the gut ecosystem can meaningfully shift outcomes in a setting where traditional immunosuppression has already come up short.

Inside the ARES trial

ARES was a single-arm, open-label Phase 3 study that enrolled 66 adults with severe GI-aGvHD across 50 centers in six European countries. These were heavily pre-treated patients: all had failed ruxolitinib after being either steroid-resistant (the vast majority) or steroid-dependent, and 91% had Grade III–IV acute GvHD with gastrointestinal involvement—the sickest end of the spectrum. 

Xervyteg was given as a third-line intervention. The primary endpoint was gastrointestinal overall response rate (GI-ORR) at Day 28, capturing complete responses and very good partial responses. Secondary endpoints included all-organ response rates at different time points and overall survival.

By Day 28, GI-ORR was 62%, with 38% of patients achieving a complete response and another 20% reaching a very good partial response. All-organ response at the same time point was similarly high at 64%, again driven mainly by complete and very good partial responses. Those numbers would be encouraging in any late-line context; in ruxolitinib-refractory GI-aGvHD, they are notable.

What mattered just as much to clinicians in the room was durability. At Day 56, GI-ORR remained 47% and all-organ ORR 45%, with most responses still complete. At three months, both GI-ORR and all-organ ORR were 44%, again with a predominance of complete responses. In other words, this was not just a transient blip in symptoms; a substantial share of patients maintained meaningful disease control over time on the back of a short course of microbiome therapy. 

Survival: separating responders from non-responders

Response is encouraging, but survival is what ultimately counts. In ARES, the 12-month overall survival rate for the entire cohort was 54%, with median overall survival not reached at the time of analysis. That already compares favorably with historical expectations for this high-risk population, though of course cross-trial comparisons must always be handled with caution. 

The survival split between responders and non-responders is where the signal becomes particularly striking. Patients who achieved a GI response at Day 28 had a 12-month overall survival of 68%, while non-responders had a survival rate of just 28%. Median overall survival for non-responders was a mere 54 days. Statistically, the difference was highly significant (p<0.0001), but even without the p-value, the clinical message is clear: if Xervyteg induces an early gut response, those patients are far more likely to still be alive a year later.

From a mechanistic standpoint, this makes intuitive sense. Severe GI-aGvHD is driven by a vicious cycle of mucosal damage, dysbiosis, inflammation, and barrier breakdown. If you can interrupt that loop early—restore barrier function, dampen inflammation, and rebuild a more tolerant immune-microbiome relationship—you don’t just relieve diarrhea. You remove a major engine of systemic complications.

Safety in ARES was described as acceptable for such a fragile population, with continuous oversight from an independent Data and Safety Monitoring Board. There was no new safety signal linked to the use of a pooled-donor microbiome product in this context, which will be reassuring to regulators and clinicians accustomed to worrying about infectious risks with any fecal-derived therapy.

What exactly is Xervyteg?

Xervyteg (MaaT013) is not a single-strain probiotic capsule. It is a so-called Microbiome Ecosystem Therapy™: a standardized, off-the-shelf preparation derived from pooled stool from carefully selected healthy donors, co-cultivated and manufactured under cGMP conditions, and delivered as an enema in the hospital setting. 

Pooling donors and using MaaT’s proprietary co-cultivation platform is intended to ensure high microbial diversity and batch-to-batch consistency, two features that traditional one-donor fecal microbiota transplantation can struggle with. The product is enriched for what the company calls its “Butycore™” community—bacterial species known to produce butyrate and other short-chain fatty acids with anti-inflammatory properties. The therapeutic idea is to re-establish a symbiotic gut ecosystem that can help recalibrate immune responses, restoring tolerance without broadly suppressing immunity.

For MaaT, Xervyteg is the lead candidate in a broader platform that aims to position microbiome-driven immunomodulation as a new “pillar” in oncology alongside chemotherapy, targeted therapies, and checkpoint inhibitors. Beyond GvHD, the company is also exploring microbiome therapies as adjuncts to immunotherapy in solid tumors and other settings where the gut ecosystem appears to influence response to treatment. 

Regulatory countdown in Europe

The ARES dataset is not just an academic exercise. MaaT has already submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xervyteg in ruxolitinib-refractory GI-aGvHD, with a decision expected around mid-2026. The product enjoys Orphan Drug Designation on both sides of the Atlantic, reflecting the high unmet need in this narrow but very severe indication. 

If the EMA gives a green light, Xervyteg would become the first microbiome-based therapy approved in oncology anywhere in the world and the first authorized third-line treatment for aGvHD in Europe. That would be a symbolic milestone for the microbiome field, which has seen years of hype, a few disappointments, and only a handful of regulatory successes so far, mainly in the prevention of recurrent C. difficile infection.

For transplant centers, an approval would almost immediately force conversations about where Xervyteg should sit in treatment algorithms, how to identify ideal candidates, and how to integrate a microbiome enema into already complex inpatient pathways. For payers, the question will be how to value a therapy that is neither a classic biologic nor a small molecule, but a living ecosystem that potentially prevents ICU stays, invasive infections, and expensive salvage therapies.

Business implications: from platform story to product story

On the business side, MaaT is at an inflection point. For several years, the company has positioned itself as a platform play—leveraging its Microbiome Ecosystem Therapies, bioinformatics tools such as gutPrint®, and a vertically integrated manufacturing footprint. With ARES, Xervyteg becomes a tangible product with a clear clinical value proposition and a defined initial market: adult patients with severe, ruxolitinib-refractory GI-aGvHD across Europe and potentially the UK. 

The company has already moved to prepare for commercialization. In mid-2025, MaaT signed an exclusive licensing, distribution, and commercial supply agreement with Clinigen for Xervyteg in the European Economic Area and the UK. Clinigen will handle distribution and market access in these regions, while MaaT focuses on manufacturing and further R&D, a division of labor that should help a relatively small biotech avoid the costs and delays of building a pan-European commercial infrastructure from scratch. 

Financially, MaaT has supplemented equity capital with non-dilutive funding, including a €37.5 million loan from the European Investment Bank announced in 2025, earmarked to support scale-up of its microbiome manufacturing and expand the oncology pipeline. 

All of this points to a clear strategic arc: secure EMA approval and first commercial revenues in GvHD, demonstrate real-world impact and safety at scale, and then leverage the same technology and know-how into additional oncology indications where the microbiome’s role is increasingly evident.

A new pillar or a niche solution?

From a wider industry perspective, ARES will be watched for at least three reasons.

First, it tests a genuinely new therapeutic modality in a setting where conventional immunosuppression has already failed. If Xervyteg’s benefits are borne out in real-world experience, it will strengthen the case for microbiome ecosystem therapies as more than “supportive care” and push regulators and guideline committees to define their place in serious disease management.

Second, ARES is a pivotal trial in a narrow but clinically important space. That makes Xervyteg unlikely to become a mass-market blockbuster in its initial indication, but it could become a highly valued, high-price, hospital-only product that consolidates MaaT’s reputation and supports further pipeline risk-taking—similar to how some rare disease drugs have underpinned biotech growth stories.

Third, the study will reopen debates about trial design in microbiome therapeutics. ARES is single-arm, without a randomized comparator, which means that comparisons to historical controls are unavoidable but imperfect. Regulators will have to weigh the severity of the condition, the ethical and logistical challenges of randomizing patients who have exhausted approved therapies, and the strength of the survival and response signals. If EMA is satisfied, it could set a precedent for future microbiome products in ultra-high-need indications.

What comes next

For now, MaaT is preparing a full publication of the ARES data in a peer-reviewed journal and working its way through the EMA review process. Clinicians will want to see detailed safety breakdowns, subgroup analyses, and microbiome-response correlations. Health economists and payers will run models on potential cost offsets. Investors will watch for regulatory interactions and any hints on pricing strategy.

But the broader narrative is already emerging. In a disease that strikes the most fragile cancer patients at one of the most precarious moments in their care, a therapy built from restored microbial diversity has delivered durable responses and a survival signal that is hard to ignore. Whether Xervyteg ultimately becomes a new standard third-line option or remains a specialized tool in expert centers, ARES has pushed the microbiome field another step away from theory and closer to routine clinical practice.

For the first time, probiotics – long relegated to the grey zone between food and medicine – have been subjected to the same type of socio-economic scrutiny that EU institutions usually reserve for air pollution or hazardous chemicals. The result is a comprehensive Socio-Economic Impact Assessment (SEA) commissioned by IPA Europe and prepared by Rud Pedersen Public Affairs together with Holland, a consultant who has spent decades valuing the health and economic impacts of policy choices for the European Commission, the European Environment Agency and the OECD.

From clinical benefit to economic value

The Brussels meeting was structured in two acts. First came the science. Dutch immunologist Ger T. Rijkers walked the audience through a global analysis of probiotic clinical trials: 504 studies, 73,558 patients and 405 different outcome parameters. 

When those trials were scrutinised using a stringent definition of success – significant improvement in at least one predefined clinical endpoint and a parallel gain in patient-reported quality of life – the picture was clear: across metabolic, gastrointestinal and other indications, probiotics consistently conferred measurable health benefits. Most of the studies used well-known strains such as Lactobacillus rhamnosus GG and Bifidobacterium animalis BB-12, but there was also a growing body of work on multi-strain formulations. 

In other words, the biological and clinical rationale for probiotics is no longer the weak link. Over the past two decades, microbiome research has shown how live microorganisms can modulate immune responses, restore microbial balance after antibiotic use, influence lactose digestion, support oral and vaginal health, and even affect mental well-being through the gut–brain axis.

The real novelty in Brussels lay in the second act: Holland’s attempt to translate those clinical effects into hard euros using the EU’s own Better Regulation methodology and the OECD System of Health Accounts.

Seven common conditions, one big bill

The SEA focuses on seven areas where the scientific evidence for probiotic benefits is strong and where the burden of disease in Europe is substantial:

• antibiotic-associated diarrhoea (AAD) and restoration of gut microbiota after antibiotic use
• upper respiratory tract infections (URTIs, mostly common colds and flu)
• oral health
• women’s reproductive health, particularly bacterial vaginosis
• lactose intolerance
• mental health via the microbiota–gut–brain axis
• bowel function, with an emphasis on constipation in older adults.

For each of these, the team mapped three things: how many people are affected in the EU, what probiotics can realistically change (incidence, severity, duration of symptoms), and what those changes are worth when you add up direct healthcare costs, productivity losses and, where possible, intangible costs such as reduced quality of life.

Where robust “response functions” existed – relative risk reductions or odds ratios from meta-analyses – the team used them directly. Where the literature was thinner, they modelled the impact of a very modest 1% improvement in the burden of disease, precisely because that figure is easy to scale and conservative compared with many of the observed clinical effects.

Even under those cautious assumptions, the numbers are striking.

Where the savings come from

Take antibiotic-associated diarrhoea, a frequent complication of systemic antibiotics. AAD not only causes discomfort and prolonged recovery for patients; in hospitals it drives extra laboratory tests, additional medications, isolation measures, longer stays and occasional intensive-care admissions, especially in cases caused by Clostridioides difficile.

Using EU data, Holland estimates that C. difficile infections alone cost around €3.2 billion per year in direct healthcare expenditure. When other causes of AAD are included, the total burden is closer to €16 billion annually. Probiotics administered alongside antibiotics have been shown to reduce the risk of AAD by 37% in adults and 53% in children. Applying those effect sizes, the model suggests that wider prophylactic use of probiotics could save €1.2–1.7 billion per year on C. difficile-linked AAD and €5.9–8.5 billion when all AAD cases are considered.

A second example is respiratory health. Upper respiratory tract infections are so common that they are often dismissed as trivial, yet they generate a sizeable bill in GP consultations, prescriptions and, above all, lost work days. For the EU-27, the SEA estimates direct healthcare costs of URTIs at around €57 billion per year, with productivity losses ranging between €61 and €349 billion depending on the assumptions used.

Here, Holland’s team drew on previous modelling from Lenoir-Wijnkoop and colleagues in France. Extrapolated to the EU, and still focusing only on those patients who actually see a doctor (about one third of flu cases and just 1% of common colds), the preventive use of probiotics could yield €1.1–3.9 billion per year in combined healthcare and productivity savings. When the full burden of respiratory infections is considered, each 1% improvement in respiratory health attributable to probiotics corresponds to €1.2–4.1 billion in economic benefit annually.

The picture is similar in bowel function. Constipation affects up to 42% of older people in long-term care facilities, with clear implications for quality of life and staff workload. In this setting alone, the SEA estimates baseline costs at €3.8 billion per year in pharmaceuticals and nursing time. Clinical data suggesting a 28% reduction in constipation episodes with probiotic use translate into potential savings of around €1.4 billion per year, without even counting gains in the community-dwelling elderly or working-age adults.

For lactose intolerance, the model assumes that probiotic foods can reduce symptoms by about 50%, thereby allowing many individuals to consume dairy without discomfort. Given the knock-on effects on diet quality, bone health and productivity, the estimated benefit for paid and unpaid work is €7–9.5 billion per year.

In women’s health, probiotics added to standard treatment for bacterial vaginosis are estimated to improve first-line cure rates from 48% to 83%. That difference matters because BV is associated with preterm birth, greater susceptibility to sexually transmitted infections and pelvic inflammatory disease. Across the EU, raising cure rates to this level would reduce direct costs linked to BV and its co-morbidities by €1.9–3.9 billion per year.

Finally, when the team looked at oral health and mental health, they could not derive firm response functions, but they could estimate the value of incremental improvements. Given that poor oral health costs the EU €143–193 billion per year, a mere 1% improvement would be worth €1.4–1.9 billion annually. For mental illness and autism combined, each 1% improvement in symptoms and participation corresponds to around €5.9 billion in societal benefit.

When all these elements are added up, and after accounting carefully for overlaps and uncertainties, Holland concludes that the benefits of wider probiotic use in Europe comfortably exceed €10 billion per year, and could in reality be several times higher once intangible benefits and under-studied conditions are included.

“These are very common conditions”

Speaking after his presentation, Holland underlined that the analysis is deliberately conservative. The team only counted benefits where some reasonable link to probiotic use could be supported by published data, and in several domains settled for modelling a 1% improvement even though clinical trials often show much larger effects.

He also stressed that the conditions chosen – colds and flu, antibiotic-related diarrhoea, constipation, lactose intolerance, oral disease, bacterial vaginosis, mental health issues – are extremely common across the EU population. Many people suffer from several of them over the course of a year, and they frequently co-exist or lead to comorbidities such as cardiovascular disease or psychological distress. Better prevention in these areas, even if modest on an individual level, therefore translates into large system-level gains.

From a health-economic perspective, probiotics are unusual in that they sit at the crossroads of healthcare and everyday consumption. They are purchased by citizens in supermarkets or pharmacies, yet their cumulative impact – positive or negative – shows up in hospital budgets, sickness-benefit statistics and productivity figures. The Brussels study is one of the first attempts to capture that link in a structured way using standard EU impact-assessment tools.

A regulatory paradox

The SEA does not stop at numbers; it also highlights a striking regulatory paradox. Europe has a centuries-old tradition of fermented foods, a strong scientific base in microbiome research and substantial public investment in microbiome-related projects under Framework Programmes and Horizon Europe. Yet, under current EU food law, “probiotic” is not even a legally recognised category.

Because the term has been interpreted by the European Commission as a health claim in itself, its use on labels is tightly restricted. EFSA, for its part, has applied very stringent criteria to probiotic health claims, approving only a single generic claim to date (for live yoghurt cultures improving lactose digestion), while rejecting more than 350 others.

The result is regulatory fragmentation. Countries such as Italy, France and Spain have developed their own pragmatic guidelines, allowing the word “probiotic” to appear on foods and supplements under specific conditions, while others either prohibit the term or treat it as a mandatory but non-communicative descriptor.

For consumers, this patchwork creates confusion. A large survey across eight EU countries found that 57% of probiotic users feel poorly informed about whether products actually contain probiotics, and 79% would like clearer labelling. Holland’s report notes that, if better information persuaded even a portion of these consumers to use probiotics more consistently, the European market could expand significantly – with preventive health benefits and budgetary effects following closely behind.

For producers, the lack of harmonisation means higher compliance costs and legal uncertainty that can deter innovation and investment, particularly in new strains and formulations emerging from cutting-edge microbiome science.

What this means for doctors, policymakers and industry

The message from Brussels was not that probiotics are a magic bullet. Holland repeatedly pointed out that his work does not constitute a formal systematic review of all health and economic data, and that the analysis remains partial – particularly for intangible costs and for conditions such as neurodegenerative disease where the evidence base is still emerging. If anything, the bias in the SEA is towards underestimating the benefits.

But the combination of Rijkers’ clinical overview and Holland’s economic modelling leaves little doubt that ignoring probiotics in preventive strategies is no longer intellectually or fiscally neutral.

For clinicians, the findings strengthen the case for integrating evidence-based probiotic products into care pathways where benefits are most clearly documented – for example alongside antibiotics in high-risk patients, in the management of recurrent bacterial vaginosis, or as part of multi-modal strategies for constipation in older adults and lactose intolerance.

For policymakers, the SEA offers something they rarely have in this field: an order-of-magnitude estimate of what a more coherent probiotic policy could be worth in euros, using the same language and methods that underpin impact assessments in other sectors. It also suggests a route forward: formal recognition of the WHO/FAO definition of probiotics as a category, science-based and proportionate criteria for use of the term “probiotic” on labels and in communication, and a clear distinction between general descriptive use and specific health claims.

For industry, the implication is that aligning innovation pipelines with these seven high-burden conditions – and generating solid strain-specific data – could position probiotics not just as consumer wellness products, but as credible partners in EU strategies on life sciences, One Health and antimicrobial resistance.

In Brussels, Holland summed up his conclusions with characteristic understatement: even small improvements in common conditions, achieved through safe, widely acceptable interventions such as probiotics, can unlock savings on a scale that matters for national health budgets. The challenge now lies with regulators, healthcare systems and industry leaders to decide whether they are willing to treat probiotics as part of serious prevention policy – and not just as a line on the supermarket shelf.

At the heart of the event is a new socio-economic assessment (SEA), commissioned by IPA Europe from an external expert and based on OECD and EU Better Regulation methodologies. The study examines how a more enabling regulatory framework for probiotic foods and food supplements could translate into economic value, in term of reduction of  healthcare expenditure . It compares scenarios with and without probiotic use in seven areas supported by strong scientific evidence, with a focus on microbiome and gut health, immune support and food-related well-being.

For businesses, the current regulatory vacuum in the EU has very tangible costs. While the term “probiotic” has been recognised internationally since the 2001 WHO/FAO definition and is formally accepted in markets such as the US, Canada, Brazil and several Asian countries, the EU still lacks a harmonised legal category for probiotic foods and food supplements.  In practice, this forces companies to navigate a patchwork of national rules: Italy, France, Spain and other Member States have developed their own guidance, while others accept the term on supplements only. Multiple label versions, fragmented compliance strategies and legal uncertainty all increase production costs and weigh on investment decisions.

IPA Europe argues that this situation undermines the single market and erodes the EU’s position in a fast-growing global sector. Clear EU-wide criteria for using the term “probiotic” – including strain-specific identification, safety and stability requirements, minimum effective dose and shelf-life viability – would provide a level playing field, support innovation and give consumers transparent information at the point of sale.  The association also stresses that moving beyond a narrow, health-claim-only approach would align with the European Commission’s broader Vision for Agriculture, as well as its strategies on biotechnology, life sciences and preventive healthcare.

The Brussels event will open with market insights on the current state of the probiotic sector in Europe and worldwide. A panel debate with representatives from the European Commission, the European Parliament, scientific bodies and consumer-facing organisations will then explore how a coherent EU framework for probiotics could simultaneously boost competitiveness, safeguard consumers and support public health objectives.

A press briefing immediately after the meeting is expected to amplify the policy debate beyond the room. For industry players, the event offers a rare opportunity to see their regulatory challenges translated into economic language that resonates with finance ministries and competition-minded policymakers. For Brussels decision-makers, it provides a data-driven basis to revisit the EC  2007 guidance that is widely seen as outdated and out of step with both science and the market.

Ultimately, the question facing the EU is not whether probiotics matter — the science and consumer demand suggest they do — but whether Europe is prepared to give this category a clear, predictable framework that allows companies to invest and innovate at scale. On 2 December, IPA Europe hopes to move that conversation decisively forward.

Collecting the first clues

The search began with a simple but powerful idea: to explore the gut ecosystem in the earliest stage of life. Samples collected from 26 healthy babies, all breastfed and delivered naturally, became the starting point for this scientific journey. These infants, only a few months old, had guts still untouched by weaning or extensive environmental exposure, a pristine microbial landscape, a treasure trove for those who knew how to look.

Back in the laboratory, the samples became the raw material for a painstaking journey of isolation. Scientists plated them on selective media, incubated them under strictly controlled conditions, and examined the colonies that emerged. What might have looked like anonymous specks on agar plates soon revealed their identities under genetic sequencing: dozens of strains belonging to the familiar probiotic families of Lactobacillus and Bifidobacterium. From this microbial crowd, only a handful would pass the rigorous tests ahead.

The criteria were exacting. Any candidate strain had to survive the hostile environment of the human stomach, rich in acid and bile salts. It had to prove its ability to cling to intestinal cells, since without adhesion there could be no meaningful interaction with the host. Safety came next, particularly the absence of transferable antibiotic resistance genes. Finally, the strains were tested for their ability to influence immune cells, those sentinels of the body that decide whether to tolerate, resist, or respond. Each step was a hurdle, and many promising candidates fell by the wayside.

Three probiotic protagonists emerge

Out of this arduous selection process, three names began to stand out: Bifidobacterium breve 2TA, Lacticaseibacillus rhamnosus L13B, and Lactobacillus gasseri L6. Each strain, property of Coree srl, brought to the table a different kind of strength, and together they illustrated the diversity of probiotic potential hidden in the microbiome of infants.

• Bifidobacterium breve 2TA distinguished itself in its dialogue with the immune system. When exposed to human dendritic cells in vitro, this strain promoted their maturation and influenced cytokine production, tilting the immune balance toward a more active state. Though Bifidobacterium strains often struggle to withstand the harsh chemistry of the stomach, 2TA showed that survival is not the only metric of value; its ability to interact with the immune system suggested a role as a subtle but powerful modulator in the infant gut.
• Lacticaseibacillus rhamnosus L13B, on the other hand, excelled where persistence and growth mattered. It demonstrated a robust capacity to adhere to intestinal cells, ensuring it could remain in place long enough to act. Even more intriguingly, it grew successfully in reconstituted skimmed milk, hinting at the possibility of incorporation into dairy-based functional foods. Its immune profile was equally notable, stimulating pro-inflammatory cytokines such as IL-1β and TNF-α, responses that might be useful in enhancing defenses against pathogens during early life.
• Then came Lactobacillus gasseri L6, perhaps the most resilient of the trio. Unlike many strains that faltered when faced with simulated gastric transit, L6 survived with little loss of viability. It also showed one of the highest levels of adhesion to intestinal cells, positioning itself as a hardy colonizer. In immune tests, it modulated certain co-stimulatory molecules, although its effect was more modest than that of its counterparts. Still, its endurance marked it as a strain capable of real persistence in the gut environment, a quality indispensable for long-term probiotic action.

Together, these three strains represented more than just new microbial names. They illustrate a broader concept: probiotics are not interchangeable entities but unique biological actors, each defined by its own metabolic and immunological profile. Their discovery reinforces the idea that the future of probiotic science lies in precision, identifying strains that match specific physiological needs or life stages.

Beyond the Petri dish: the promise of personalized probiotics

The story does not end here. For now, the evidence rests on in vitro characterizations, a crucial first step but not the final proof of probiotic efficacy. The next chapters will need to be written in the form of clinical trials, safety validations, and perhaps the development of functional foods or infant formulas that bring these strains from Petri dish to everyday life. Yet even at this early stage, their story resonates as a reminder of how deeply connected we are to the invisible organisms that share our bodies, and how much remains to be discovered when we look at them with fresh eyes.

In the end, Bifidobacterium breve 2TA, Lacticaseibacillus rhamnosus L13B, and Lactobacillus gasseri L6 are not just bacteria: they are witnesses to the intimate, ancestral dialogue between mothers, infants, and microbes. They remind us that the quest for health sometimes begins not in distant laboratories, but in the very first days of life, carried quietly in the gut of a newborn.

The collaboration made its first debut during SupplySide Global, in late October, and is now poised to take center stage at Food Ingredients Europe (FiE) in Paris from December 2–4, with its own booth, n. 73SU33, in order to drive this partnership forward.

Today, consumers are increasingly health-conscious and seek functional benefits even in their everyday foods, including yogurt, skyr, and other dairy products. However, despite the widespread use of the label “live and active cultures,” most of these products do not contain well-defined strains in research-validated quantities supported by scientific evidence. As a result, the benefits delivered do not always match consumers’ expectations.

SkyrBiotics^® powered by SynBalance serves as both a consumer-facing platform and an ingredient solution for dairy brands, bridging Icelandic innovation with Italian microbiome science. With the support of SynBalance, SkyrBiotics^® offers a targeted approach that integrates carefully selected and validated biotic solutions, transforming conventional dairy products into high-value functional foods.

Not just generic claims, but specific strains, clear dosages, and transparent communication — setting a new standard of credibility and authenticity for the dairy sector.

Your Premium Dairy Solution
For producers, this means access to outstanding scientific know-how, the opportunity to differentiate through premium offerings in an increasingly competitive market, and a credible way to communicate value and information to customers. For consumers, it means clear recognition, quality assurance, and documented benefits, easily identified by the SkyrBiotics^® powered by SynBalance logo and supported through the SkyrBiotics^® consumer portal.

Through this collaboration, the Icelandic tradition of dairy innovation merges with Italian scientific expertise to drive the future of functional nutrition — moving yogurt, skyr, and other dairy products into a new era of health-driven innovation.

The Future of Dairy is Functional.
SkyrBiotics^® Powered by SynBalance — from Iceland, via Italy, to the world. Is your brand ready to join the functional dairy future?

SynBalance srl

info@synbalance.care | www.synbalance.care

LinkedIn: https://www.linkedin.com/company/synbalance-probiotics/

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SkyrBiotcs

info@skyrbiotics.is | skyrbiotics@synbalance.care | www.skyrbiotics.is

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The ARES study enrolled 66 adult patients across 50 centers in Austria, Belgium, France, Germany, Italy, and Spain—a real-world geography that matters when regulators and payers later weigh generalizability. These were profoundly sick individuals: 91% had severe disease at baseline, with more than half classified as grade III and a third as grade IV. All had failed on ruxolitinib and were either resistant or dependent on steroids, leaving clinicians with few options and patients with dwindling odds.

Against that backdrop, the topline story is unusually clear. The trial met its primary endpoint, delivering a Day-28 gastrointestinal overall response rate (GI-ORR) of 62% (41/66), driven largely by complete responses and very good partial responses. That early efficacy signal—originally disclosed in January—now comes with a richer portrait. Responses proved durable: GI-ORR was maintained in 49% of evaluable patients at Day 56 and in 44% at three months, with an average response duration of 6.4 months. Importantly for a condition where mortality looms, survival curves separated decisively. The estimated 12-month overall survival for the full cohort was 54% at a median follow-up of 140.5 days, but patients who achieved a GI response at Day 28 had a markedly higher estimated one-year survival than non-responders (67% versus 28%), a difference the company reports as statistically significant. In responders, median overall survival had not been reached; in non-responders, it was just 54 days.

Taken together, the data point to a therapy with both speed and stamina—an early response that can be maintained over time and that appears to translate into a survival advantage. In a single-arm design like ARES, the survival correlation is particularly telling. While cross-trial comparisons are fraught, the magnitude of the Day-28 response and the durability metrics will inevitably become anchors in conversations with hematologists weighing third-line choices, and with health-technology assessors evaluating value in the face of limited alternatives.

Safety, often the Achilles’ heel of therapies in fragile post-transplant populations, features favorably in the company’s summary. While full safety tables will be reserved for the ASH podium and a subsequent publication, MaaT Pharma’s framing—“strong efficacy and a favorable safety profile”—is consistent with the company’s platform thesis that restoring a balanced microbiome can modulate immune responses without compounding toxicity. For clinicians who have watched gut GvHD spiral despite best efforts, the proposition of clinically meaningful benefit that does not exact an unmanageable safety toll is compelling.

The business implications are equally clear. Xervyteg® is under active review by the European Medicines Agency following a June 2025 MAA submission, with a decision anticipated in the second half of 2026. Should EMA grant approval, Xervyteg® could become the first approved third-line treatment specifically for patients with GI-aGvHD who have failed steroids and ruxolitinib—an important label distinction that would define its early market and guide uptake patterns. The European footprint of the ARES sites is strategically helpful; post-approval, those centers can serve as early adoption hubs and training grounds for standardized administration pathways.

For MaaT Pharma itself, these results validate more than a single asset. They reinforce the broader premise of Microbiome Ecosystem Therapies™—consortia designed to reconstitute gut microbiota in a way that meaningfully shapes immune function. Over nearly a decade of ASH visibility, the company has steadily expanded its hematology-oncology narrative; now, with Phase 3 evidence in hand, it can engage regulators, payers, and transplant centers from a position of strength. The timing also aligns with a market that is increasingly attuned to the microbiome’s role in transplant outcomes and immunotherapy responses, yet still hungry for rigorously generated, late-stage data.

Execution will matter from here. Between the ASH presentation and the EMA opinion expected in 2H 2026, MaaT Pharma will need to convert clinical momentum into operational readiness: manufacturing scale for a living-ecosystem product, a distribution model that respects the time-sensitive needs of transplant units, medical-affairs programs capable of stewarding onboarding across 50-plus European centers and beyond, and health-economics dossiers that translate response durability and survival separation into cost-effectiveness arguments. The survival delta between responders and non-responders, if sustained as datasets mature—including the planned one-year OS readout by the end of 2025—could become the linchpin of those value narratives.

Clinically, the ASH audience will probe nuances: response kinetics by baseline severity, organ involvement beyond the gut, steroid-resistant versus steroid-dependent subgroups, concomitant medications, infectious complications, and any signal that helps triage which patients might benefit most and how soon after ruxolitinib failure to intervene. If Xervyteg® can consistently convert early responses into longer-term survival gains without exacerbating infection risk, it will carve out a distinct role in treatment algorithms that have long relied on improvisation once first and second lines fail.

There is also a symbolic current running beneath the numbers. For years, microbiome therapeutics have oscillated between hype and skepticism, buoyed by elegant biology but slowed by translational hurdles. ARES suggests the field is now stepping across that threshold in one of medicine’s most unforgiving arenas. Should regulators agree and transplant teams adopt, Xervyteg® would not only address a dire clinical need; it would also mark a watershed for ecosystem-level therapies in oncology and immunology.

MaaT Pharma arrives at ASH with data that read like a turning point—credible, durable efficacy in a population with few options, safety that appears manageable, and a regulatory path that could culminate in Europe within the next year after decision. For patients facing GI-aGvHD after transplant, the promise is concrete: a potential third-line therapy where there has long been a gap. For the company and the broader microbiome sector, the message is larger still: late-stage, practice-changing microbiotherapy is no longer theoretical. It’s ready for the main stage.

This approval marks an important milestone, further strengthening the scientific credibility and clinical effectiveness of our probiotic complex, already internationally recognized as a Finalist at the NutraIngredients Asia Awards 2025.

Taking care of skin health through the gut–skin axis is crucial: it helps promote a more radiant, hydrated, balanced, and visibly healthier complexion, while potentially reducing signs of aging and skin discomforts such as acne and atopic dermatitis.

With the authorization from Health Canada, SynBalance strengthens its credibility and visibility in the North American market, promoting closer relationships with local partners and customers.

ProBeautyShield strains have been authorized for the following skin claims:

• Help relieve symptoms such as skin tightness, dryness, itching, and burning in mild to moderate cases of atopic dermatitis (eczema).
• Helps improve symptoms such as skin tightness, dryness, itching, and burning associated with mild to moderate atopic dermatitis (eczema).
• Helps to improve symptoms such as skin roughness associated with atopic dermatitis (eczema).
• Helps provide relief from symptoms such as skin tightness, dryness, itching, and burning associated with atopic dermatitis,
• Clinically shown to help reduce symptoms such as skin tightness, dryness, itching, and burning associated with atopic dermatitis.
• Source of probiotics to help support skin health in people with atopic dermatitis,
• Helps to support skin moisture and smoothness in those with mild atopic dermatitis
• Helps to support skin hydration and smoothness in those with mild atopic dermatitis

This achievement was possible thanks to our Canadian partner Prebionature, which has over 30 years of experience in building strong partnerships with brands in Canada and abroad. SynBalance is proud to celebrate this significant milestone, reached through dedication, commitment, and mutual collaboration. Obtaining Health Canada approval is the result of a long and rigorous process, and we are pleased to have accomplished this goal side by side. Together, we are building a solid partnership to bring SynBalance to local and international brands seeking distinctive differentiation and added value in skin health solutions.

“We are thrilled that an institution as rigorous as Health Canada has recognized the quality and scientific value of ProBeautyShield” said Cristiana Piangiolino, Managing Director of SynBalance SRL. “This achievement reflects our dedication to developing innovative, science-backed probiotic ingredients. We also want to extend our gratitude to our partner Prebionature for their invaluable support throughout this journey.”

With this important milestone, SynbÆctive® ProBeautyShield is set to become a trusted solution for skin health across Canada.

Health Canada’s approval opens up new market opportunities, further reinforcing the presence of SynbÆctive® ProBeautyShield and confirming its value as a reliable solution for skin health worldwide.

About SynBalance SRLSynBalance develops and studies proprietary probiotic strains belonging to Lactobacilli and Bifidobacteria, available as branded ingredients, customized formulations, or white-label solutions. Its mission is to provide clinically proven probiotics, derivatives, and other microbiome-related technologies, supporting health through the prevention of chronic diseases and aging. SynBalance’s portfolio is designed to target multiple health areas, including women’s health, the gut–skin axis, mental health, cardiovascular prevention, and immune system support, through respectful and sustainable modulation of the intestinal microbiota. The company’s versatile business model ensures efficacy, competitiveness, and speed to market