MaaT Pharma: positive results in ALS
MaaT Pharma announces positive Phase 1b results, with the primary endpoint for the evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS) met.
The single-arm, open-label, exploratory Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in ALS met its primary endpoint of safety and tolerability of multiple doses of MaaT033.
The independent Data Safety and Monitoring Board (DSMB) concluded that MaaT033 showed a good safety and tolerability profile in ALS patients after two months' administration.
A preliminary microbiota analysis confirms the successful implantation of beneficial bacteria from MaaT033, the Company's oral capsule, reinforcing the safety and tolerability results.
Pr. Gaëlle Bruneteau, PhD, Professor of Neurology at the Sorbonne University and consultant neurologist at the ALS Expertise Center at the Pitié-Salpêtrière Hospital, Paris, France, said: "The Phase 1b results, which underline the good safety and tolerability profile of MaaT033 in ALS, are encouraging. Preclinical and clinical evidence suggests a role for the gut microbiota in the pathogenesis and variability of ALS, and further studies are needed to fully explore the potential of the gut-brain axis in this disease. '
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