The FDA verbally informed Fulcrum Therapeutics Inc (NASDAQ: 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. One Step Qrt-Pcr
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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This article FDA Slams Break On Fulcrum Therapeutics' Sickle Cell Disease Study, Shares Plummet originally appeared on Benzinga.com
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