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Domagrozumab (PF-06252616) clinical studies evaluating the treatment of Duchenne Muscular Dystrophy terminated by Pfizer

A Phase 2 safety and efficacy study (B5161002) and an open label extension study (B5161004) evaluating Domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy has been terminated by Pfizer. Duchenne muscular dystrophy (DMD) is a rare, serious, debilitating childhood genetic disease characterized by progressive muscle degeneration and weakness and significantly shortened life expectancy. It generally affects boys with incidence rate being 1 in every 3500 to 5000 live male births each year. General symptoms of the disease include difficulty in getting up, running or climbing stairs, late walking, manifesting in early childhood days usually in the ages of 1 to 4 years. The disease generally leads to a loss of ability to walk in early teenage years, use of mechanical ventilator support leading ultimately to cardiomyopathy in later years.

The Phase 2 study (B5161002) was a two year double blind, placebo-controlled, multicenter clinical trial administered in monthly IV doses in 121 boys aged 6 to 15 years with DMD, regardless of underlying mutation. The open label extension study (B5161004) was designed to evaluate long term safety and efficacy of domagrozumab. The Phase 2 study's (B5161002) primary end point which was to demonstrate a difference in the mean change from baseline in 4 Stair Climb (in seconds) following one year of treatment with domagrozumab as compared to placebo in patients with DMD was not met. The secondary endpoint was also not met which was totality of evidence to demonstrate a significant treatment effect.

The decision of terminating the study was taken by Pfizer after thorough review of data available at the time of primary analysis which evaluated all study participants after one year of treatment as well as those participants who were in the trial beyond one year. The studies were not terminated because of safety reasons. However the data review by Pfizer will continue in order to have better understanding and Pfizer will share the results with the scientific and patient community.