Entrada Therapeutics shares plummeted almost 30% after it announced that the U.S. Food and Drug Administration (FDA) has refused to lift its clinical hold on its Phase 1 study of its investigational therapeutic ENTR-601-44 for Duchenne muscular dystrophy.
The Boston-based biopharmaceutical company announced last December that the FDA had issued a hold on its Investigational New Drug (IND) application for its planned study.
It said on Wednesday that, despite providing additional information to the FDA which supported the initiation of its Phase 1 clinical trial of the drug in the United Kingdom in September, the agency has declined to lift the hold.
“We are disappointed that the U.S. clinical hold has not been lifted, especially given the strength of the data package submitted to the FDA,” Entrada CEO Dipal Doshi said in a statement.
“It’s important to emphasize that the ongoing ENTR-601-44 development program continues to progress, with ENTR-601-44-101 clinical data expected in the second half of 2024.”
The company has completed dosing for the first and second cohorts in its Phase 1 trial in the United Kingdom.
“In parallel with the Phase 1 clinical trial, we continue to plan for the global development of ENTR-601-44 which will include clinical trials in patients with Duchenne who are exon 44 skipping amenable,” Doshi said.
He added that the company would re-engage with the FDA to discuss the next steps “in due course.”
Entrada shares traded down 28.3% at US$11.95 shortly before noon on Wednesday.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on X, formerly known as Twitter, @emilyjjarvie