More Trouble For Foghorn Therapeutics: After Blood Cancer Trial, FDA Puts Another Cancer Trial On Clinical Hold

  • The FDA has put Foghorn Therapeutics Inc's FHTX study on partial hold after a patient had a severe heart-related safety event.
  • The company said to pause enrollment on its Phase 1 trial of FHD-609 in patients with synovial sarcoma and SMARCB1-deleted tumors. 
  • A sarcoma patient who received the second-highest dose of its drug candidate had a grade 4 QTc prolongation event that could lead to a life-threatening arrhythmia (irregular heartbeat).
  • Foghorn said, "Patients in the affected cohort were dose reduced, and additional safety measures have been discussed with and provided to the study investigators."
  • Enrollment in the dose escalation portion of the study has been completed, and a maximum tolerated dose has been identified. The company is not at this time planning to pursue a dose expansion study independently.
  • In May 2022, the FDA instituted a partial clinical hold on Foghorn Therapeutics' Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). 
  • The FDA requested a review of the safety database, risk mitigation strategies, and clinical activity breakdown across dose levels.
  • In August 2022, the FDA placed a full clinical hold on the Phase 1 dose escalation study of FHD-286.
  • The company anticipates providing clarity on the development path for FHD-286 in AML/MDS in 1H of 2023.
  • Price Action: FHTX shares are down 17.7% at $5.53 on the last check Monday.
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