Bayer discontinues phase II Liplong study

Bayer Schering Pharma has announced that an independent Data Safety and Monitoring Board (DSMB) has

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.