Pfizer Inc. (PFE - Free Report) announced that it has terminated two clinical studies evaluating its pipeline candidate, domagrozumab, in patients with Duchenne muscular dystrophy (“DMD”), a progressive muscle degeneration disease. The two studies included a phase II study evaluating the candidate in patients regardless of underlying mutation and another was an open-label extension study.
The company took the decision as domagrozumab failed to meet the primary endpoint in the phase II study.
The primary endpoint of the study was to show a difference in mean change from baseline in 4 Stair Climb after one year of treatment with domagrozumab versus placebo.
An analysis of secondary endpoints also showed lack of a “significant treatment effect”.
Pfizer stated that the discontinuation of the studies was not due to safety concerns. The company will continue to review the data to get better insights.
However, the company continues to develop its mini-dystrophin gene therapy, PF-06939926,for the treatment of DMD.
The company’s shares have increased 14.5% so far this year compared to the industry’s rise of 5.1%.
Domagrozumab is designed to work by inhibiting myostatin, a protein involved in muscle growth. Shares of Scholar Rock (SRRK - Free Report) , which is also developing a similar treatment for DMD, slid 9.7%, following Pfizer’s termination of studies.
Sarepta Therapeutics’ (SRPT - Free Report) Exondys 51 is the first drug to receive approval for the treatment of DMD. However, it has a different mechanism of action. Sarepta and Solid Biosciences Inc. (SLDB - Free Report) are also developing gene therapy programs for the treatment of patients with DMD.
DMD is a progressive muscle degeneration, which weakens the patient as well as significantly reduces life expectancy. The disease has serious impacts as it can lead to loss of ability to walk, cardiomyopathy or put patients on mechanical ventilator support. Per the press release, the disease affects one person in every 3500 to 5000 live male births annually.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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