Biotech MaaT Pharma’s microbiome drug candidate, MaaT013, is not out of the woods just yet, according to the U.S. FDA.
The French pharma company initially submitted its Investigational New Drug (IND) application in June 2021 to initiate an open-label, single-arm phase 3 clinical trial of the drug in the U.S., but received a clinical hold letter two months later. MaaT submitted a request for a Type A meeting, as well as detailed responses to the agency’s questions.
Now, in a letter shared this week, the FDA is asking MaaT to provide more information on the safety and efficacy of the pooling of donor material used for the product before the clinical hold is lifted.
MaaT013 is intended to act as a full-ecosystem microbiome restoration biotherapeutic agent, and it was being assessed in patients with Acute Graft-versus-Host Disease (aGvHD). GvHD is a serious complication of allogeneic stem cell transplantation, in which the donated bone marrow or stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body.
To manufacture the drug, the company pools donor samples, combines them and then enriches them to yield a more diverse microbiotic therapy. According to MaaT Pharma, the product has stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species.
MaaT says it is now in the process of preparing the next steps in the interaction with the FDA, potentially requesting another Type A meeting dedicated to discussing the remaining questions.