FDA Lifts Clinical Hold of Dyne’s Duchenne Muscular Dystrophy IND

The FDA has lifted a clinical hold it placed in January on Dyne Therapeutics’ investigational new drug (IND) application for DYNE-251 for treatment of certain patients with Duchenne muscular dystrophy.

The disease is characterized by an inability to manufacture dystrophin, leading to gradually reduced muscle function. DYNE-251 is designed to create an alternative pathway for muscle cells to manufacture dystrophin and slow deterioration of cardiac and skeletal muscle.

In placing the hold, the FDA had asked for additional clinical and non-clinical details.

With the clinical hold lifted, the company plans to begin dosing participants in a phase 1/2 clinical trial.