MaaT Pharma Completes Patient Recruitment for Phase 2a Trial of MaaT013 with Immune Checkpoint Inhibitors in Metastatic Melanoma

MaaT Pharma, a clinical-stage biotech firm specializing in Microbiome Ecosystem Therapies™ (MET), has announced the successful completion of patient recruitment for a Phase 2a clinical trial. The trial, known as PICASSO, is a randomized controlled study that began in April 2022 and has enrolled 70 patients across five centers in France. The trial is evaluating the safety and efficacy of MaaT013, a product candidate developed by MaaT Pharma, in combination with immune checkpoint inhibitors ipilimumab (Yervoy®) and nivolumab (Opdivo®). The primary endpoint of the study is safety, with the first efficacy data expected to be available by the end of 2024 or early 2025.

MaaT013 is designed as a full-ecosystem, off-the-shelf therapy for acute hospital use, characterized by its high microbial diversity and the presence of Butycore™, a group of bacteria known for producing anti-inflammatory metabolites. The therapy aims to restore the symbiotic relationship between the patient's gut microbiome and immune system, correcting immune function responsiveness and tolerance to reduce steroid-resistant gastrointestinal aGvHD. The US FDA and EMA have granted Orphan Drug Designation to MaaT013.

MaaT Pharma has a robust platform, gutPrint®, for identifying new disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions. The company's MET therapies are produced through a standardized cGMP manufacturing and quality control process, ensuring the safe delivery of the full microbiome diversity in liquid and oral formulations. MaaT Pharma is committed to integrating microbiome therapies into clinical practice with the support of leading scientists and established regulatory relationships. The company is listed on Euronext Paris under the ticker MAAT.

The PICASSO trial is funded by the Directorate of Health Care Supply (DGOS) and operated by the French National Cancer Institute (INCa) as part of a project call (PHRC-K19-183). The study's findings are anticipated to be submitted to a scientific journal in the last quarter of 2024 or the first quarter of 2025, marking a significant milestone in the field of microbiome-based cancer therapies.