The PICASSO trial: painting a new future for melanoma patients

MaaT Pharma indicates completion of patient recruitment for the Phase 2a RCT Evaluating MaaT013 in combination with immune checkpoint inhibitors in metastatic melanoma.

In a recent landmark development in the fight against metastatic melanoma, MaaT Pharma, a pioneering force in Microbiome Ecosystem TherapiesTM (MET), has announced the successful completion of patient recruitment for its Phase 2a PICASSO trial. This trial, a collaborative effort with AP-HP, INRAE, and Institut Gustave Roussy, delves into the potential of MaaT013, the company’s flagship product, in conjunction with immune checkpoint inhibitors (ICIs), specifically ipilimumab and nivolumab, to combat this aggressive form of skin cancer.

The trial, which commenced in April 2022, saw the enrollment of 70 patients across five distinguished centers in France. MaaT Pharma has not only provided the MaaT013 drug and placebo for this trial but is also contributing to the microbiome profiling of patients with its proprietary gutPrint® research engine. The trial’s primary endpoint, safety, will be assessed at Week 27, with the first efficacy data, determined by the best overall response rate as per immunological Response Evaluation Criteria in Solid Tumors (iRECIST), also being made available.


MaaT013 represents a significant stride in MET, being a full-ecosystem, off-the-shelf, standardized pooled-donor enema therapy. Its unique composition boasts a high diversity and richness of microbial species, including the ButycoreTM group known for their anti-inflammatory metabolites. The therapy aims to restore the symbiotic relationship between the patient’s gut microbiome and their immune system, potentially correcting immune function responsiveness and tolerance.

The implications of this trial are far-reaching, touching upon the symbiotic relationship between our microbiome and immune system and their role in cancer treatment. The PICASSO trial, funded by the Directorate of Health Care Supply (DGOS) and operated by the French National Cancer Institute (INCa), marks a critical phase in this innovative approach to cancer therapy. With the unblinding set for Week 27, the medical and scientific communities eagerly await the results, which could herald a new era in the treatment of metastatic melanoma and beyond.

This trial’s outcomes, anticipated to be communicated in late 2024 or early 2025, promise to shed new light on the potential of microbiome ecosystem therapies in oncology. As MaaT Pharma continues to forge ahead, its efforts underscore the growing importance of microbiome-based therapies in modern medicine, potentially offering new hope to patients battling metastatic melanoma and other formidable diseases.