Novo Nordisk Halts Clinical Studies Evaluating Concizumab (anti-TFPI mAb) for Hemophilia A and B With or Without Inhibitors

Shots:

• Novo Nordisk has paused its two P-III clinical studies (explorer7 and 8) and one P-II clinical study (explorer5) investigating concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status
• The studies have been paused due to the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing P-III program. Novo Nordisk and DMC are evaluating the relevance of the events for the continuation of the program, yet no conclusions have been made
• In Oct’2019, P-III explorer7 has initiated to establish the safety and efficacy of concizumab (qd, SC) delivered in a pen device for reducing the number of bleeds. The explorer8 study was initiated in Nov’2019 which enroll ~293 patients from 32 countries while P-II explorer5 study was started in Oct’2017

Click here to­ read full press release/ article | Ref: Novo Nordisk | Image: The Diabetes Times