MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,announced that the exploratory single-arm, open-label Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in ALS has met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses. The independent Data Safety and Monitoring Board (DSMB) concluded that MaaT033 showed good safety and tolerability in ALS patients when dosed for two months. Preliminary microbiome analysis confirms the successful engraftment of MaaT033, the Company’s oral capsule, outlining further the safety and tolerability outcome.
Prof. Gaëlle Bruneteau, Professor of Neurology at Sorbonne University and consultant neurologist at the Paris ALS expert center of the Pitié-Salpêtrière Hospital, Paris, France stated “I am encouraged by these Phase 1b results, which underscore the strong safety and tolerability profile of MaaT033 in ALS. Preclinical and clinical evidence suggests a role of the gut microbiota in the pathogenesis and variability of ALS and further studies are essential to fully explore the potential of the gut-brain axis in this disease.”
Additional study endpoints are expected to be analysed in the coming months. Based on the current evidence from the Phase 1b IASO study, the DSMB supports proceeding to Phase 2. MaaT Pharma plans to determine the next steps based on a comprehensive analysis of the study’s overall data, expected in early 2025. These steps may include initiating a larger randomized controlled efficacy study, subject to appropriate funding options.
Hervé Affagard, CEO and co-founder of MaaT Pharma shared “I want to express my full gratitude to the patients participating in this study while battling a devastating disease. The ALS trial represents a potentially transformative milestone in our mission to improve patient survival through innovative microbiome-based immune modulation therapies. These results demonstrate the potential versatility of our platform to address critical unmet medical needs across multiple therapeutic areas. As we look toward expanding the reach and impact of this innovation, we will explore collaboration opportunities to accelerate and broaden its application to benefit even more patients in need.”
A total of 15 participants across two centers in France have been enrolled in the Phase 1 trial. This Study has been a collaborative effort involving leading researchers, clinicians from Hôpital de la Pitié-Salpêtrière – AP-HP and University Hospital of Lille, experts from the French academic FILSLAN/ ACT4ALS-MND and the French patients’ association Tous en Selles contre la SLA. These results, along with previous data from the Phase 1b CIMON trial in Acute Myeloid Leukemia and the latest DSMB for the ongoing Phase 2b trial PHOEBUS in Europe, bolster confidence in MaaT033’s safety profile in continued use.
Key safety and tolerability data will be presented in a poster at the 35th International symposium on ALS/ MND taking place in December 6-8, 2024, in Montreal, Canada.
