One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a tri­al test­ing a mi­cro­bio­me ther­a­py in pa­tients with steroid-re­sis­tant acute graft-ver­sus-host dis­ease (aGVHD).

A year af­ter MaaT Phar­ma’s IND ap­pli­ca­tion in the US was first met with a clin­i­cal hold, the French biotech said the agency is main­tain­ing the hold. The crux of the mat­ter, MaaT sug­gest­ed, has to do with the way it puts to­geth­er its drug can­di­date, which is ad­min­is­tered as an en­e­ma (i.e. an in­jec­tion of flu­id in­to the bow­el).

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