Drug major Pfizer Inc. (PFE) announced Tuesday that the pivotal Phase 3 BASIS clinical trial (NCT03938792) evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects.
Marstacimab is a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people without inhibitors to Factor VIII (FVIII) or Factor IX (FIX).
It was administered weekly with flat (not weight-based) dosing in the trial as a subcutaneous 300 mg loading dose followed by 150 mg once weekly.
The BASIS trial demonstrated that prophylactic treatment with marstacimab resulted in a statistically significant and clinically relevant reduction in annualized bleeding rate (ABR) in people living with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.
Marstacimab, if approved, has the potential to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B.
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