MaaT Pharma Announces U.S. FDA Lifts Clinical Hold on Phase 3 Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease

MaaT Pharma, a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported that the Food and Drug Administration has lifted the clinical hold and cleared the Investigational New Drug (IND) application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 to treat gastrointestinal acute Graft-versus-Host Disease (aGvHD) as a third line of treatment.

“We are grateful for the FDA’s continued engagement and are very pleased with the lift of the hold on MaaT013’s IND application. 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. This 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.,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. “The U.S. represents an important market for our therapeutics, and we have already benefited from our previous discussions with the FDA by adapting our pooling technology for our entire pipeline according to the guidelines received during this regulatory process.”

In parallel to the resolution of the clinical hold with the FDA, the development of MaaT013 has significantly progressed in the ongoing international multicenter open-label, single-arm, pivotal Phase 3 trial (ARES) launched in March 2022 in Europe, along with the ongoing accumulation of encouraging data from the Early Access Program. In this context, before initiating clinical activities in the U.S., MaaT Pharma intends to consult with the FDA on the next steps of the regulatory process to bring MaaT013 to US acute Graft-versus-Host Disease patients in the most expeditious way possible while the Company continues the late-stage clinical development of MaaT013 in Europe.

“Today’s positive answer is also an exciting moment for MaaT Pharma in its mission to help patients through safe and innovative medicines. It also confirms the robustness of our protocols for donor screening and selection which are now authorized for clinical evaluation in the U.S. as well as in Europe. We are now in a position to start discussions with the FDA for the clinical evaluation of MaaT033, our second drug-candidate, in the U.S.,” added Mr. Affagard. “This step forward for us will also contribute to progress across the microbiome field and confirms MaaT Pharma’s position as a leader in the industry.”