MaaT Pharma, a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, announced that eClinicalMedicine has published clinical data on MaaT013 as a treatment for acute Graft-versus-Host Disease (aGvHD).
The data includes results from 24 patients in a Phase 2 clinical trial and 52 patients enrolled in the Early Access Program (EAP) in France. The article entitled “Pooled allogeneic faecal microbiota MaaT013 for steroid-refractory gastrointestinal acute graft-versus-host disease: a single-arm, multicentre phase 2 trial” can be accessed here.
MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (i.e., a group of bacterial genera known to produce immuno-regulatory metabolites). It aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use.
“Data show encouraging clinical outcomes and survival rates for very severe patients with acute GvHD, thereby opening new treatment avenues,” said Pr. Florent Malard, Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University. “Based on this promising clinical data, including the good tolerability and safety profile, we eagerly anticipate the results of the ongoing evaluation of MaaT013 in Phase 3.”
“The publication of our results in a peer-reviewed journal underlines the importance of the microbiome in the hematology-oncology field. Indeed, the data suggests that the successful re-establishment of a functional microbiome through our innovative MET MaaT013 is associated with patient response,” commented Hervé Affagard, CEO and co-founder of MaaT Pharma.
The Phase 2a HERACLES trial evaluated MaaT013’s safety and efficacy in patients with grade III-IV steroid-refractory gastrointestinal aGvHD after allogeneic hematopoietic stem cell transplantation. The gastrointestinal Overall Response Rate was 38% in the trial population and 58% in the EAP population. Interestingly, patients responding at day 28 exhibited a higher microbiota richness and greater proportions of MaaT013-derived beneficial species from multiple donors, that could suggest a clinical impact from pooling donors. MaaT013’s safety profile was consistent with previous findings. Clinical data in the article were also previously presented at the 2021 American Society of Hematology Annual Meeting. For HERACLES, Overall Survival (OS) in responding patients at the 12-month follow-up was 44%, compared to 13% in non-responders (OS in all included patients was 25% at 12 months). For EAP, the 12-month OS in responding patients was 59%, compared to 7% in non-responders (OS in all included patients was 38% at 12 months). As a reminder, OS in ruxolitinib-resistant patients at 2 months is 22% (REACH1 study). The drug candidate MaaT013 is currently being evaluated in the pivotal ARES study, the first global phase 3 trial in hemato-oncology.