Health. A major innovation developed in Lyon

The therapeutic prospects are significant. "The idea is to use the microbiota as a health co-factor for prevention and treatment," explains Dr. Nicolas Benech, a gastroenterologist at the Croix-Rousse Hospital who co-founded the Microbiota Study Group, which brings together around thirty specialists on the subject in the Auvergne-Rhône-Alpes region.

Lyon-based biotech company Maat Pharma, which develops drugs derived from the intestinal microbiota (formerly called "intestinal flora") to improve the survival of patients treated for blood cancers, has announced that it has filed a Marketing Authorization Application (MAA) with the European Medicines Agency. MAA is a mandatory prerequisite for any potential marketing of a pharmaceutical specialty.

If approved, the drug candidate MaaT013 (branded under Xervyteg) could become the first microbiota-based drug approved in Europe, and the first in the world for hematology-oncology.

Its principle is to restore the intestinal microbiota through cancer treatments, particularly immunotherapies. To do this, it uses fecal matter from donors with a healthy microbiota. This area of ​​therapeutic innovation, which involves re-implanting the microbial community of healthy donors via stools into patients who need it, is still in its infancy on a global scale. But it opens up very promising therapeutic horizons.

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At the beginning of 2025, Maat Pharma's stock price rose by more than 13% following the announcement of the success of clinical trials of its drug candidate, MaaT013, which improves the survival of patients treated for blood cancers by restoring their microbiota.

“Submitting our Marketing Authorization Application (MAA) to the EMA represents a major regulatory milestone for MaaT Pharma and a significant advancement for patients with refractory aGvHD—a life-threatening complication of stem cell transplantation, for which there are currently no approved treatments ,” said Hervé Affagard, co-founder and CEO of MaaT Pharma. “Today, we are one step closer to providing a long-awaited therapeutic option, and we remain fully committed to the development of microbiota-derived immunomodulatory technologies in hematology-oncology, a field marked by significant unmet medical needs. ”

Last January, Maat Pharma published the results of the final phase of the clinical trial evaluating the efficacy and safety of this drug candidate. After 28 days of administration of MaaT013, the gastrointestinal status of 62% of the 66 participating patients with graft-versus-host disease had improved, far exceeding the expected 38% response rate.

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