Dyne Therapeutics: FDA Clears IND Application To Initiate Clinical Trial Of DYNE-251

(RTTNews) - Dyne Therapeutics, Inc. (DYN) announced the FDA has lifted the clinical hold and cleared the company's Investigational New Drug application to begin a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy amenable to skipping exon 51. The company expects to begin dosing patients in a phase 1/2 trial evaluating DYNE-251 in mid-2022.

Dyne Therapeutics said the trial aims to enroll 30 to 50 ambulant and non-ambulant males with Duchenne, who are age 4 to 16 and have mutations amenable to exon 51 skipping therapy.

Shares of Dyne Therapeutics are up 9% in pre-market trade on Tuesday.