After 20-month hold, FDA drops resistance to fecal pooling, clears MaaT to run pivotal trial

Twenty months after being rocked by a clinical hold, MaaT Pharma has finally received the green light from the FDA to run a phase 3 trial of its pooled fecal therapy in gastrointestinal acute graft-versus-host disease (GvHD) patients in the U.S.

The FDA issued the hold in August 2021 in response to MaaT’s request to run a late-stage trial of MaaT013. The biotech had answered the FDA’s clinical and manufacturing-related questions a year later but had yet to resolve sticking points related to its mixing of fecal donations from multiple donors. To MaaT, the approach is a way to improve diversity and standardization. To the FDA, it was a concern. 

The French company gave its most upbeat update yet in February of this year, revealing that the FDA had provided a list of conditions for studying MaaT013. Now, the biotech has met the conditions and the FDA has lifted the clinical hold. 

“This is the first time the agency has authorized the phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology, which provides greater bacterial diversity, in a standardized and scalable approach, with the goal of safely improving patients’ outcomes,” Hervé Affagard, CEO and co-founder of MaaT, said in a statement. 

Affagard added that the “major milestone is fundamental to the strategic decisions regarding the development of our portfolio outside Europe and to the company’s outlook in the U.S.” Exactly how the lifting of the clinical hold will shape MaaT’s plans remains unclear.

Noting the progress of its European phase 3 trial, which began 13 months ago, and “encouraging data” from an early access program, MaaT said it plans to talk to the FDA before starting clinical development in the U.S. The talks are intended to identify “the most expeditious way” to bring MaaT013 to patients in the U.S. while MaaT continues late-stage clinical development in Europe.

The European study has a primary completion data of the end of September, per MaaT expected its cash to fund operations into the second quarter of next year when it provided an update last month.