Pfizer’s DMD gene therapy falls short in phase 3 trial

Pfizer’s gene therapy candidate for Duchenne muscular dystrophy failed to meet its primary endpoint in a phase 3 trial, the company said June 12. 

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The study tested the experimental medication, fordadistrogene movaparvovec, among about 100 boys aged 4 to 7 with the rare genetic condition. After one year of treatment, the research did not prove efficacy in the primary endpoint — motor function improvement — or in the secondary endpoints — 10-meter run/walk velocity and time to rise from floor velocity. 

The safety profile was manageable, Pfizer said in a news release. The drugmaker’s phase 2 trial of fordadistrogene movaparvovec recently paused dosing after a child died. 

In summer 2023, the FDA awarded Sarepta Therapeutics the first gene therapy for Duchenne muscular dystrophy.

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