The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority).
However, no safety concerns were raised. As a result of the DSMB findings and recommendation, the company has decided to discontinue the study.
Liplong is a randomized, double-blind active comparator controlled study designed to demonstrate the non-inferiority of BAY79-4980 infused in hemophilia A patients once a week, as compared to Kogenate FS, antihemophilic factor (recombinant), which is infused three times per week
Kemal Malik, member of the board of Bayer Schering Pharma and head of global development, said: "While we are disappointed with the outcome of the analysis, we remain committed to developing our long-acting recombinant factor VIII compounds. It is our goal to enable once weekly prophylaxis dosing as well as other factor therapies, such as BAY VII, a modified recombinant factor VII therapy for hemophilia A and B in patients with inhibitors."
Furthermore, Bayer has sought scientific advice from regulatory agencies for the clinical development of a directly PEGylated recombinant factor VIII molecule, which in preclinical models has a doubled half-life. Proof of concept trials in humans are scheduled to start in late 2010.
Further analysis of the Liplong data will be carried out over the next months.