Bayer discloses anticoagulant drug trial plans

Bayer has revealed its plans for clinical trials featuring its investigational compound, rivaroxaban, an oral anticoagulant.

The German pharmaceutical company and its development partner, Ortho-McNeil, state that some 20,000 patients are to be recruited for phase III studies of the drug. One of them, designed to assess rivaroxaban’s effect in the prevention of strokes in atrial fibrillation, will start in the next few weeks.

Another phase III trial is planned to begin recruiting in early 2007, where researchers will examine the drug for the treatment of venous thromboembolism.

Bayer claims the drug could have some value since oral anticoagulants are not currently available – apart from warfarin, which needs frequent dosage monitoring and also interacts with some types of food and drugs.

Kemal Malik, head of global development and Bayer Healthcare’s chief medical officer, commented: “There currently exists significant medical need for an oral anticoagulant that does not require extensive and costly monitoring.”

“In studies conducted to date, rivaroxaban has demonstrated safety and efficacy across a wide range of doses and we look forward to the results of these studies,” he added.

Bayer and Ortho-McNeil are targeting a regulatory filing of the drug during 2010.

Previous attempts to develop an oral anticoagulant to replace warfarin – which has been a standard therapy for over 50 years – have been met with mixed results. AstraZeneca produced Exanta, which it hoped could be the breakthrough drug needed to replace warfarin. However, Exanta was withdrawn permanently after reports of liver toxicity.