MaaT Pharma reported that the advisory committee provided input on which patient groups to include in the upcoming Phase 2 trial though specific details were not disclosed in the press release.

In ALS, an imbalanced gut microbiome comprising bacteria and other microbes is common and contributes to inflammation in the brain and spinal cord potentially accelerating disease progression and reducing survival. To address this MaaT Pharma developed MaaT033 an oral therapy containing beneficial bacteria from healthy donors. These freeze-dried microbes are encapsulated and swallowed aiming to repopulate the gut and restore microbial balance.

Originally developed for certain leukemia patients MaaT033 was expanded into ALS trials based on growing evidence of the gut-brain connection.

Recognizing the urgent need for new ALS treatments and driven by our commitment to support those affected we leveraged our discovery platform to explore this new therapeutic area showing its potential beyond oncology said Hervé Affagard CEO and co-founder of MaaT Pharma.

The IASO trial included ALS patients who had been experiencing symptoms for six months to two years. It was a single-arm open-label study meaning all participants received MaaT033 and both they and their doctors were aware of the treatment.

Over the three-month treatment period MaaT033 was well tolerated with no reported side effects successfully meeting the trial’s primary safety endpoint. Bacterial strains from the therapy were detected in most patients’ guts within the first month indicating successful and rapid colonization.

Disease progression was monitored using the Revised ALS Functional Rating Scale (ALSFRS-R) which assesses patients’ ability to perform daily tasks. Prior to treatment patients were losing a median of 0.7 ALSFRS-R points per month. During the 84-day course of MaaT033 this rate slowed to 0.3 points per month suggesting a potential deceleration in disease progression.

Neurofilament protein levels biomarkers of nerve cell damage remained stable throughout the study.

These Phase 1b results underscore the potential of microbiome-targeted therapies in slowing ALS progression and support further exploration of gut-brain axis modulation in neurodegenerative diseases beyond oncology.

Source: https://alsnewstoday.com/news/bacteria-mix-aid-gut-microbiome-slow-als-progression/