Foghorn Therapeutics Says FDA Places Clinical Hold On Phase 1 Dose Escalation Study Of FHD-286

(RTTNews) - Biotechnology company Foghorn Therapeutics Inc. (FHTX) announced Tuesday that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on the Phase 1 dose escalation study of FHD-286, an inhibitor of BRG1/BRM, in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).

The dose escalation Phase 1 study of FHD-286 in metastatic uveal melanoma (mUM) continues per protocol. The company plans to report data from the mUM study in the first half of 2023.

The full clinical hold in the AML/MDS study is due to the observation, in the data submitted in response to the partial hold, of additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286.

The FDA has additional questions and requires further analyses before the clinical hold may be lifted.