- The FDA verbally informed Fulcrum Therapeutics Inc FULC that it has issued a full clinical hold regarding the Investigational New Drug (IND) application for FTX-6058 for the potential treatment of sickle-cell disease.
- The Agency indicated that it would provide a formal Clinical Hold Letter to the company within 30 days.
- The Agency initiated the clinical hold due to previously reported preclinical data.
- Fulcrum will suspend dosing in the Phase 1b trial of FTX-6058.
- "Fulcrum intends to address questions related to modulation of the PRC2 complex and the preclinical data," said Robert J. Gould, Fulcrum's interim president & CEO.
- FTX-6058 is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED) discovered using FulcrumSeek, Fulcrum's proprietary discovery engine.
- Inhibition of EED leads to potent downregulation of key fetal globin repressors, thereby causing an increase in fetal hemoglobin (HbF).
- FTX-6058 is being developed for sickle cell disease and other hemoglobinopathies.
- FTX-6058 is currently in Phase 1b trial in sickle cell disease.
- Initial data demonstrated proof-of-concept and achieved absolute levels of HbF increases associated with potential overall patient benefit.
- The company says that to date, FTX-6058 has been generally well-tolerated, with no drug-related serious adverse events.
- Price Action: FULC shares are down 53.22% at $6.03 on the last check Friday.
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