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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today presented results from the pivotal Phase 3 BASIS clinical trial (NCT03938792) evaluating marstacimab for the treatment of people with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). The results from the BASIS trial demonstrated a statistically significant and clinically meaningful effect on annualized bleeding rate (ABR). The findings were presented today at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego.
“For more than five decades, the most common treatment for hemophilia A and B has been intravenous infusions that are often administered multiples times per week,”1 said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Infectious Diseases, Research and Development, Pfizer. “Based on these results and if approved, we believe marstacimab could offer a subcutaneous option with a compelling combination of efficacy and safety that may significantly reduce the risk of bleeding. We look forward to potentially bringing this treatment option to people living with hemophilia A and B without inhibitors.”
In the BASIS trial, 116 people living with hemophilia were treated with marstacimab during a 12-month active treatment period (ATP) versus a routine prophylaxis (RP) and on-demand (OD) intravenous regimen with FVIII or FIX, administered as part of usual care in a six-month observational period. Marstacimab, a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI), was administered weekly with flat (not weight-based) dosing as a subcutaneous 300 mg loading dose followed by 150 mg once weekly. The study found:
