Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its bispecific antibody (BsAb) Mim8, used for the treatment of haemophilia A. The trial successfully met its primary endpoints, which focused on the reduction of treated bleeding episodes.
The study demonstrated that once-weekly and once-monthly administrations of Mim8 achieved reductions of 97% and 99% in treated bleeding episodes compared to no prophylaxis treatment. Furthermore, the therapy fully prevented treated bleeds in 86% and 95% of patients receiving once-weekly and once-monthly Mim8, respectively, marking a significant improvement from the 0% prevention rate without prophylaxis.
Among patients who had previously received coagulation factor prophylaxis treatment, once-weekly and once-monthly Mim8 reduced treated bleeds by 48% and 43%, respectively. It also successfully prevented treated bleeds in 66% and 65% of these participants.
The safety and tolerability profiles of Mim8 were found to be consistent with previous studies, with no fatalities or thromboembolic events reported. Novo Nordisk anticipates securing the first regulatory approval for Mim8 by the end of this year.- Flcube.com
