FDA lifts clinical hold of MaaT Pharma's lead microbiome therapeutic trial

Shares of French biotech Maat Pharma (Euronext Paris: MAAT) edged up more thatn 2% to 9.70 euros this morning, after it revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold and cleared it Phase III Investigational New Drug (IND) application for lead microbiome ecosystem therapy (MET) candidate, MaaT013, in patients with acute Graft-versus-Host Disease (aGvHD).

Maat noted that is a significant milestone for the microbiome space, as well as for the company, as this is the first time the FDA has authorized the Phase III clinical evaluation of a microbiota-based live biotherapeutic based on a pooling (process of combining multiple donor samples) technology, in the USA.

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 III trial (ARES) launched in March 2022 in Europe, along with the ongoing accumulation of encouraging data from the Early Access Program.