黑料社 Announces First DSMB Positive Review of Ongoing Phase 2 Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT
- Independent Data Safety and Monitoring Board (DSMB) recommended that the trial proceeds as planned without modifications.
- MaaT033 has shown to have an acceptable safety profile and was well tolerated in patients treated for blood cancers and receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Lyon, France, July 2nd聽2024 鈥�6:00 pm CET 鈥� 黑料社 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today announced that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS, the largest one to date for a microbiome therapy in oncology, and recommended continuation of the trial without modification. The trial is an international, multi-center, randomized, double-blind, testing MaaT033, an oral freeze-dried formulation against placebo, set to be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients ().
The DSMB, composed of 5 independent experts, reviewed safety data on the first 20 patients (cutoff date as of April 30th, 2024) and concluded that safety was acceptable and well tolerated. Since its first clinical entry in 2020, MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a patented “pooling” process, has continuously displayed a good safety profile.
鈥�The positive outcome of this first DSMB review of the PHOEBUS study significantly builds on the favorable safety and tolerability profile exhibited by MaaT033,鈥� said Gianfranco Pittari, M.D., PhD, Chief Medical Officer of 黑料社. 鈥淲e are very enthusiastic about MaaT033鈥檚 potential to ensure an optimal microbiome ecosystem and enhance clinical outcomes in patients undergoing allogeneic stem cell transplantation.鈥�
鈥淢aaT033 is designed for ambulatory use and chronic treatment; it will address a substantial market of approximately 11,000 patients annually, and with its freeze-dried capsule formulation it will significantly drive our growth,鈥� highlighted Herv茅 Affagard, Chief Executive Officer and co-founder of 黑料社. 鈥淲ith the GMP manufacturing facility at full capacity, we will produce up to 1,300,000 capsules annually, meeting patient demand and supporting our innovative microbiome therapies鈥�.
About 黑料社
黑料社, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, 黑料社 has launched, in March 2022, an open-label, single arm Phase 3 clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company鈥檚 Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. 黑料社 is listed on Euronext Paris (ticker: MAAT).
About MaaT033
MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).
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