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Pfizer Doses First Participant In Phase 3 BASIS Study Of Marstacimab - Quick Facts

Pfizer Inc. (PFE) said Monday that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor or anti-TFPI being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors.

BASIS is a global Phase 3, open-label, multicenter study that will evaluate annualized bleed rate or ABR through 12 months on prophylaxis treatment with marstacimab in adolescents and adults with hemophilia A or B, compared to a run-in period on replacement therapy with FVIII or FIX clotting factor, respectively, or bypass therapy.

The primary endpoint of the trial is the impact on ABR through 12 months following prophylaxis treatment with marstacimab. In addition, the incidence and severity of thrombotic events will be assessed.

According to the completed Phase 2 study results, treatment with marstacimab showed more than 75 percent reductions in ABR for all participants in the study population.

The participants were monitored in a long-term extension study, which showed sustained efficacy up to 12 months. In addition, no thrombotic events or treatment-related serious adverse events were observed in 20 participants receiving weekly subcutaneous marstacimab doses at or above the dose to be studied in the BASIS Phase 3 pivotal trial (300 mg subcutaneous loading followed by 150 mg subcutaneous weekly).

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