Fulcrum Therapeutics announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its sickle cell disease therapeutic FTX-6058, sending its shares almost 40% higher in pre-market trading.
The company said it had worked with the FDA to resolve the clinical hold, which was issued on February 23, 2023, and that it intends to commence an amended Phase 1b trial for FTX-6058.
The hold was related to preclinical data submitted in 2022 and non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2, Fulcrum noted.
“We are pleased with the FDA’s decision to lift the clinical hold and are eager to advance FTX-6058 through clinical development to address the significant unmet need in the sickle cell disease community,” Fulcrum CEO Alex Sapir said in a statement.
“Based on the initial data from the Phase 1b trial, which showed increasing levels of HbF with each dose escalation, we believe in the potential of FTX-6058 to not only shift the current standard of care but importantly, offer these patients a differentiated oral option.”
Fulcrum shares had added 39.5% at US$5.47 about an hour before the opening bell in New York.
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