MaaT Pharma (EURONEXT: MAAT) announced that its IASO Phase 1b clinical trial, evaluating the safety and tolerability of multiple doses of MaaT003 in amyotrophic lateral sclerosis (ALS), has met its primary endpoint.
Additional study endpoints are expected to be analyzed in the coming months. Based on the current evidence from the IASO trial, the Data Safety and Monitoring Board (DSMB) supports advancing to Phase 2.
In a statement, Gaëlle Bruneteau, professor of neurology at Sorbonne University and consultant neurologist at the Paris ALS Expert Center of the Pitié-Salpêtrière Hospital, Paris, France, said, “I am encouraged by these Phase 1b results, which underscore the strong safety and tolerability profile of MaaT003 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.”
Hervé Affagard, co-founder and CEO of MaaT commented, “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,” Mr. Affagard added.
