Bayer says Ph II BAY79-4980 recombinant Factor VIII trial will not meet primary endpoint

German drug major Bayer Schering Pharma AG, Germany has announced that an independent Data Safety and Monitoring Board has completed an interim analysis of a Phase II trial (the LIPLONG study) of the company's long-acting recombinant factor VIII, BAY79-4980. The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority). No safety concerns were raised. As a result of the DSMB findings and recommendation, Bayer 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 with Kogenate FS, antihemophilic factor (recombinant), which is infused three times per week.

"While we are disappointed with the outcome of the analysis, we remain committed to developing our long-acting recombinant factor VIII compounds," said Kemal Malik, a member of the Board of Management of Bayer Schering Pharma and head of global development. "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," he added. Further analyses of the LIPLONG data will be carried out over the next months, the company noted.