Pfizer: Phase 3 Marstacimab Hemophilia Study Meets Primary Endpoints
May 30 2023 - 6:44AM
Dow Jones News
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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