The exploratory single-arm, open-label trial, named IASO, found microbiome drug MaaT-033 to be safe and well tolerated. Credit: Shutterstock / Elif Bayraktar

French-based MaaT Pharma is eyeing up a Phase II study of its immune system modulator after its Phase Ib trial in patients with amyotrophic lateral sclerosis (ALS) met all of its primary endpoints.

The exploratory single-arm, open-label trial, named IASO (NCT05889572), found MaaT-033 to be safe and well tolerated, with the company saying it plans to announce the results from its secondary endpoints in the near future.

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The company also found that preliminary microbiome analysis confirms the successful engraftment of MaaT033. Engraftment is the process by which transplanted cells travel through the blood to the bone marrow, where they begin to make new cells.

Results were validated by the Independent Data Safety and Monitoring Board (DSMB) which recommended progressing to Phase II in ALS.

The study enrolled a total of 15 patients across two centres in France, the Hôpital de la Pitié-Salpêtrière and the University Hospital of Lille.

Gaëlle Bruneteau, professor of neurology at Sorbonne University, said: “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.”

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MaaT Pharma plans to determine the next steps based on a comprehensive analysis of the study’s overall data, expected in early 2025, with the company suggesting that it might involve initiating a larger, randomised, controlled, efficacy study.

Hervé Affagard, CEO and co-founder of MaaT Pharma shared “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.”

Elsewhere in the field of microbiome therapy, Microbiotica has dosed the first subject in the Phase Ib MELODY-1 clinical trial of MB097, a precision microbiome co-therapy targeting advanced melanoma. Meanwhile, Concerto Biosciences has dosed the first subject in a Phase I trial of the three-stain live biotherapeutic product, ENS-002, aimed at treating atopic dermatitis.