Novo Nordisk (CPH: NOVO-B), a pharmaceutical company based in Denmark, has announced that its bispecific antibody (BsAb) Mim8 has successfully met the primary endpoints in a late-stage trial for haemophilia A. The trial focused on the reduction of treated bleeding episodes, with once-weekly and once-monthly doses of Mim8 showing reductions of 97% and 99%, respectively, compared to no prophylaxis treatment. Furthermore, the therapy fully prevented treated bleeding episodes in 86% and 95% of patients receiving once-weekly and once-monthly Mim8, 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 bleeding episodes by 48% and 43%, respectively. It also successfully prevented treated bleeding episodes in 66% and 65% of these participants.
The safety and tolerability profiles of Mim8 were in line with previous studies, with no reports of deaths or thromboembolic events. Novo Nordisk is optimistic about receiving the first regulatory approval for Mim8 by the end of the year.- Flcube.com