Entrada Therapeutics has shared that the FDA issued a clinical hold on the Investigational New Drug (IND) application for its ENTR-601-44 program, an exon-skipping therapy set to target individuals with Duchenne amenable to exon 44 skipping.
In a clinical hold issued prior to a clinical trial, the FDA is typically seeking additional information and has additional questions that need to be addressed about the program prior to allowing the trial to begin.
Entrada shares that they are committed to resolving the clinical hold as quickly as possible, and will provide additional updates once the FDA provides an official Clinical Hold letter within 30 days.