Is MaaT back? After 18 months on hold, microbiome biotech sees end to impasse with FDA

MaaT Pharma’s 18-month struggle to get out from under an FDA clinical hold may be entering its endgame. In its latest feedback, the agency reportedly agreed to a list of conditions that could enable clinical evaluation of the company's pooled fecal therapy MaaT013 in the U.S.

The FDA imposed a clinical hold on MaaT013 in August 2021 in response to MaaT’s request to run a phase 3 clinical trial in patients with steroid-resistant acute graft-versus-host disease. One year later, MaaT said it had answered clinical and manufacturing-related questions raised by the FDA but was yet to allay its concerns with the mixing of donations from multiple donors. 

France-based MaaT sees combining stool samples from multiple donors as a way to improve the diversity and standardization of MaaT013. But the practice has proven to be a sticking point as the biotech has tried to get the green light to study the candidate in the U.S.

MaaT’s latest update suggests the FDA’s resistance may be thawing. According to MaaT, the agency has given it a list of conditions for studying MaaT013 and thereby provided a path forward for the pooling approach in the U.S. MaaT plans to include the conditions in its IND filing. 

In a statement, Hervé Affagard, CEO and co-founder of MaaT, said the FDA has provided  “a clear and, we believe, achievable roadmap for the MaaT013 IND,” adding that he is “confident about implementing the next steps.” MaaT is yet to share a timeline for getting the trial going. 

The biotech is working against the clock. The recent deferral of a clinical trial of another drug candidate bought MaaT a little time, but it still expects its cash runway to end in the fourth quarter of 2023. MaaT is seeking fresh funding. 

News of MaaT’s progress toward the lifting of the clinical hold comes shortly after Finch Therapeutics, another biotech developing drugs based on stool samples, stopped its phase 3 trial, laid off 95% of its staff and began looking for buyers for its assets. Finch, like MaaT, was slowed down by concerns about the potential for stool-based products to transmit SARS-CoV-2 in the COVID-19 pandemic.