Novo Nordisk comments on NEJM data on Phase 3 study of denecimig

The company states: “Today, the New England Journal of Medicine, NEJM, published 26-week results from the phase 3 FRONTIER2 trial evaluating the efficacy and safety of once-monthly and once-weekly denecimig in adults and adolescents 12 years of age and older with haemophilia A, with or without FVIII inhibitors. Investigational denecimig is a bispecific antibody Factor VIIIa mimetic, designed for routine prophylaxis to help the body form blood clots. It is being studied as part of the FRONTIER program across different dosing frequencies, age groups, and severities for people living with haemophilia A, with or without inhibitors. The FRONTIER2 study measured how many bleeding episodes participants experienced each year that required treatment. People who received denecimig once-monthly had significantly fewer bleeding episodes compared to their previous treatments. Specifically, they experienced nearly 99% fewer bleeds compared to on-demand treatment, and about 43% fewer bleeds than when using their regular preventive clotting factor therapy. Similarly, people who received denecimig once-weekly also had significantly fewer bleeding episodes. They experienced approximately 96% fewer bleeds compared to on-demand treatment, and about 54% fewer bleeds than with their previous preventive therapy. In the four arms of the study, zero treated bleeds were reported in 64-95% of participants receiving denecimig, depending on the arm of the trial. In the comparator arms, zero treated bleeds were reported in 0-37% of participants depending on the arm (0% for the on-demand arm, 33% for pre-study clotting factor prophylaxis arm now on once-weekly denecimig treatment, and 37% for pre-study clotting factor prophylaxis arm now on once-monthly denecimig treatment).”