The Germany-based specialty pharmaceutical company Bayer Schering Pharma AG announced in January that it has discontinued a Phase II clinical trial (the LIPLONG study) for BAY79-4980, a long-acting recombinant factor VIII (rFVIII) therapy. The decision was made after an interim analysis and subsequent recommendation by an independent Data Safety and Monitoring Board (DSMB). DSMB concluded that the study would not achieve “the predetermined efficacy endpoint (non-inferiority).” The company added that no safety concerns were raised.
LIPLONG was a randomized, double-blind active comparator controlled study designed to demonstrate the non-inferiority of BAY79-4980 infused in hemophilia A patients weekly, compared to Kogenate® FS, another of Bayer’s rFVIII products, 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, MD, member of the Board of Management of Bayer Schering Pharma AG 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.”
Bayer also reported that it will continue to analyze the LIPLONG data.
Source: Bayer HealthCare press release dated January 25, 2010