PFE Pfizer Inc

By Colin Kellaher

Pfizer on Tuesday said a Phase 3 study of its investigational hemophilia treatment marstacimab met its primary endpoints, showing statically significant and clinically meaningful effects in the bleeding disorder.

The New York drugmaker, which is studying marstacimab for the treatment of hemophilia A or B for people without inhibitors to Factor VIII or Factor IX, said the trial showed that prophylactic treatment with marstacimab resulted in a statistically significant and clinically relevant reduction in annualized bleeding rate in people with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.

Pfizer said the safety profile for marstacimab was consistent with Phase 1/2 results, and that the treatment was generally well-tolerated.

Pfizer said it is still analyzing the full study dataset, adding that it plans to discuss the study results with regulatory authorities, with the goal of initiating regulatory filings in the coming months.

The company said marstacimab, if approved, has the potential to become the first once-weekly subcutaneous treatment for people with hemophilia B and the first treatment administered as a flat dose for people with hemophilia A or B.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 30, 2023 07:29 ET (11:29 GMT)

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