MaaT Pharma's MaaT033 Phase 2 Trial Gets First DSMB Positive Review for Allo-HSCT Patients

MaaT Pharma, a clinical-stage biotechnology company specializing in Microbiome Ecosystem TherapiesTM (MET) for cancer patients, announced the positive outcome of the first safety assessment for its Phase 2b trial, PHOEBUS. This trial, the largest of its kind for microbiome therapy in oncology, is designed to test MaaT033, an oral freeze-dried formulation, against a placebo. The trial is being conducted internationally across up to 56 clinical sites and aims to enroll 387 patients.

The Independent Data Safety and Monitoring Board (DSMB), composed of five independent experts, reviewed safety data from the first 20 patients as of April 30, 2024. The board concluded that MaaT033 exhibited an acceptable safety profile and was well tolerated, recommending that the trial continue as planned without any modifications. MaaT033, which entered clinical trials in 2020, is produced by combining microbiota from multiple donors using a patented "pooling" process. This approach has consistently shown a positive safety profile.

Dr. Gianfranco Pittari, Chief Medical Officer of MaaT Pharma, expressed optimism about MaaT033's potential to enhance clinical outcomes for patients undergoing allogeneic stem cell transplantation. He emphasized the importance of maintaining an optimal microbiome ecosystem for these patients. Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma, highlighted that MaaT033 is designed for ambulatory use and chronic treatment. He noted that the product could address a substantial market of approximately 11,000 patients annually. With its freeze-dried capsule formulation, MaaT033 is expected to significantly drive the company’s growth. Affagard also mentioned that MaaT Pharma's GMP manufacturing facility is operating at full capacity, capable of producing up to 1,300,000 capsules annually to meet patient demand and support the company’s innovative microbiome therapies.

MaaT Pharma has a comprehensive approach to restoring patient-microbiome symbiosis, especially in oncology. The company is committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation. In March 2022, the company launched an open-label, single-arm, Phase 3 clinical trial in patients with acute GvHD (aGvHD), following the success of its Phase 2 trial. MaaT Pharma's discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company's Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome in both liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of microbiome therapies in clinical practice. The company is listed on Euronext Paris under the ticker MAAT.

MaaT033 is a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM that contains anti-inflammatory ButycoreTM species. It is currently being developed as an adjunctive therapy to improve overall survival in patients receiving hematopoietic stem cell transplantation (HSCT) and other cellular therapies. MaaT033 aims to ensure optimal microbiota function and address a larger patient population in a chronic setting. The European Medicines Agency (EMA) has granted MaaT033 Orphan Drug Designation.