MaaT Pharma, a French biotech focusing on the development of microbiome therapeutics, announced this week that the FDA has lifted its clinical hold on its fecal transfer drug for Graft-vs-host-Disease (aGvHD), MaaT013.
The company initially submitted its Investigational New Drug (IND) application in June of 2021 to begin an open-label, single-arm phase 3 clinical trial of the drug in the U.S., to which the FDA responded with a clinical hold letter. At the time, the agency asked MaaT to address a few clinical and manufacturing issues. But when the biotech responded, the FDA still had more questions.
In August of last year, the agency said that they would need to assess more information on the safety and efficacy of the pooling of donor material used for the product before the clinical hold is lifted. Following a type A meeting and with the support of data from European trials for the drug, the FDA has officially lifted its clinical hold and given the company the ok to start trials in the U.S. This is the first time the agency has authorized phase 3 trials for a donor based, pooled biotherapeutic.
MaaT013 is designed to act as a full-ecosystem microbiome restoration biotherapeutic agent and is comprised of pool donor samples that are then enriched to yield a more diverse macrobiotic therapy. Besides a third line of treatment for aGvHD, the drug is being evaluated for the treatment of metastatic melanoma. According to MaaT, the product has the stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species.
While the FDA has welcomed the potential of microbiome therapeutics — approving the first fecal microbiota treatment in December of 2022 — transplant sourcing has remained a top line issue for the agency.
