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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