Bayer to abandon haemophilia drug trial
25 January 2010
Bayer Schering Pharma AG, Germany today said that it was terminating phase II clinical trials for its new compound to provide alternative treatment for haemophilia.
It said that an independent data safety and monitoring board (DSMB) had completed an interim analysis of a phase II trial (the Liplong study) of the company's long-acting recombinant factor VIII, BAY79-4980, concluding 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 said, adding that it has decided to discontinue the study.
Liplong is a randomised, double-blind active comparator controlled study designed to demonstrate the non-inferiority of BAY79-4980 infused in haemophilia 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, MD, member of the board of management of Bayer Schering Pharma AG and head, global development.
Malik said, ''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.'' Further analyses of the Liplong data will be carried out over the next months.