FDA lifts near­ly two-year hold on MaaT Phar­ma's mi­cro­bio­me ther­a­py, opens door to PhI­II

Af­ter near­ly two years, the FDA has de­cid­ed a mi­cro­bio­me ther­a­py can now be test­ed in US pa­tients with acute graft-ver­sus-host dis­ease (aGVHD), lift­ing a hold that was first placed in Aug. 2021.

French biotech MaaT Phar­ma an­nounced to­day that the agency said it could start its US Phase III clin­i­cal tri­al eval­u­at­ing the safe­ty and ef­fi­ca­cy of MaaT013. The can­di­date is a mi­cro­bio­me ecosys­tem ther­a­py that’s de­rived from donors and con­tains bac­te­r­i­al species known to pro­duce an­ti-in­flam­ma­to­ry short-chain fat­ty acids, ac­cord­ing to MaaT.

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