Pfizer DMD drug update : US pharma giant Pfizer will scrap a couple of ongoing clinical trials evaluating its humanized monoclonal antibody domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD) owing to negative results.
The two trials of the Pfizer DMD drug are B5161002 – a phase 2 safety and efficacy study and B5161004 – an open-label extension study.
In the B5161002 trial, the Pfizer DMD drug domagrozumab was administered in monthly IV doses, in 121 boys with DMD, aged between 6 and 15 years, irrespective of underlying mutation.
Designed to be a two-year trial with the primary analysis to be released after one year, B5161002 failed to meet its primary efficacy endpoint, which was defined to be a difference in the mePfizeran change from baseline in 4 Stair Climb (in seconds).
This was measured after one year of treatment with domagrozumab in comparison to placebo in Duchenne muscular dystrophy patients.
Pfizer said that further assessment of the totality of evidence including secondary endpoints did not back a significant treatment effect of its DMD drug.
The pharma major said that its decision to end the two mid-stage domagrozumab clinical trials was taken after a comprehensive review of data that had come out at the time of the primary analysis, which assessed all the enrolled patients after one year of treatment, and also those patients who were in the clinical trial beyond one year.
Pfizer stated that the domagrozumab clinical trials were not scrapped for safety concerns and that it will continue to study the data to better understand any insights they may give.
Seng Cheng – Senior Vice President and Chief Scientific Officer, Pfizer Rare Disease Research Unit, commenting on the failure of the Pfizer DMD drug domagrozumab in the two ongoing trials, said: “We are disappointed by these results and while we are not progressing with the studies, the data will contribute to a greater understanding of this disease and we will evaluate the total data set to see if there is a place for this medicine in muscular diseases.
“We are extremely grateful to all those involved with this trial, especially the boys who participated, and their families.”
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