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MaaT Pharma Reports Promising ALS Results for MaaT033

Bio Tech

Business Honor
12 May, 2025

MaaT Pharma’s Phase 1b trial shows promise for microbiome-based therapy MaaT033 in ALS treatment.

MaaT Pharma, a clinical-stage biotech company with a focus on Microbiome Ecosystem Therapies™ (MET), has published additional data from its Phase 1b clinical trial evaluating MaaT033 in patients with Amyotrophic Lateral Sclerosis (ALS). With its new research in oncology via immune modulation, the firm is now investigating the therapeutic potential of microbiome-based treatments in neurodegenerative disorders.

The IASO trial (NCT05889572), an open-label, single-arm exploratory study, was initiated with 15 patients at two of the largest French hospitals, Hôpital de la Pitié-Salpêtrière and University Hospital of Lille. In November 2024, MaaT Pharma announced that the trial had achieved its main safety and tolerability endpoint after having received a positive opinion of an independent Data Safety and Monitoring Board (DSMB). An external Scientific Advisory Committee reviewed the complete data in March 2025.

Key findings are a good safety profile for MaaT033, as supported by biomarker and microbiome findings. In particular, accelerated and persistent engraftment of therapeutic bacterial strains from MaaT033 was observed, with persistent impact throughout follow-up. Furthermore, a significant reduction in rates of disease progression by ALSFRS-R scores, to be considered with caution considering the small number of the study and short follow-up.

The findings represent a major advance in using microbiome therapies to treat beyond oncology. "These results reaffirm MaaT033's potential in neurodegenerative diseases and underpin the increasingly critical role played by the gut-brain axis," said MaaT Pharma Chief Medical Officer Dr. Gianfranco Pittari.

With unmet need in ALS being high and with promising early results, MaaT Pharma is now actively seeking strategic partners to support future clinical development. The study was conducted with the assistance of the French ALS community and academic networks, pointing to the cooperative nature behind biotech innovation.