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Trial of Experimental AML/MDS Drug Put on Partial Clinical Hold

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The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on a phase I dose-escalation study of Foghorn Therapeutics’ FHD-286 in patients with relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS), according to a company press release.

FHD-286 is an oral enzymatic inhibitor of BRG1 and BRM, two proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, a key regulator of the chromatin regulatory system. Preclinical studies of FHD-286 showed anti-tumor activity in hematologic malignancies and solid tumors.

The partial clinical hold was initiated by the FDA after the report of a recent death in a trial participant with potential differentiation syndrome. Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286.

According to the press release, patients who are currently enrolled in the phase I study and benefitting from treatment can continue to receive the drug. No new patients can be enrolled until the hold is resolved. The hold does not apply to a phase I study of FHD-286 in metastatic uveal melanoma.

Source: Foghorn Therapeutics Press Release, May 2022

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