By Michael Dabaie
Magenta Therapeutics Inc. said it received a U.S. Food and Drug Administration clinical hold letter for MGTA-117 in the blood cancers acute myeloid leukemia and myelodysplastic syndrome.
The letter is related to Magenta's investigational new drug application filed in June to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia and myelodysplastic syndrome.
The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the pharmacokinetics/pharmacodynamics model to inform dose escalation decisions in addition to safety monitoring.
This doesn't relate to the toxicology or manufacturing of MGTA-117, the company said. Magenta said it has initiated the development of the bioassay and will work closely with the FDA.
"We are actively developing the bioassay requested by the FDA and do not expect significant technical challenges in its completion. We expect to request a 'Type A' meeting in the coming weeks and, if successful in resolving this remaining issue, we would anticipate opening the study in Q4 2021," said Chief Executive Jason Gardner.
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(END) Dow Jones Newswires