A year in limbo and no end in sight for MaaT's US program
The US Food and Drug Administration is not ready to let French microbiome specialist MaaT Pharma (Euronext: MAAT) continue work on its acute graft-versus-host disease (aGvHD) candidate.
In March 2021, the company announced plans to move MaaT013 into Phase III testing, after positive top-line results from a mid-stage study enrolling people with grade III-IV steroid-refractory, gastrointestinal-predominant aGvHD.
However, while the company was able to move ahead with the European portion of the study, the US FDA checked progress soon after, citing clinical and manufacturing concerns.
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