Magenta Therapeutics Receives FDA's Clinical Hold Letter On IND Of MGTA-117

(RTTNews) - Magenta Therapeutics Inc. (MGTA) said Wednesday that it has received a clinical hold letter from the U.S. Food and Drug Administration related to its Investigational New Drug Application or IND filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia or AML and myelodysplastic syndrome or MDS.

The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the pharmacokinetics (PK)/ pharmacodynamics (PD) model to inform dose escalation decisions in addition to safety monitoring. The clinical hold item identified by the FDA does not relate to the toxicology or manufacturing of MGTA-117.

Magenta expects to request a 'Type A' meeting in the coming weeks and, if successful in resolving this remaining issue, the company would anticipate opening the study in the fourth-quarter of 2021.