The two dose-finding studies included more than 1,300 patients and demonstrated safety and efficacy for BAY 59-7939 similar to the current gold standard enoxaparin, a low molecular weight heparin, in preventing the incidence of blood clotting in patients undergoing either knee or hip replacement surgery.
In contrast to enoxaparin, which must be given subcutaneously, BAY 59-7939 has the advantage that it can be administered orally. In both studies, BAY 59-7939 was given twice daily in tablet form. At the moment, additional studies are investigating the efficacy and safety of administering BAY 59-7939 to patients once a day.
“The results are extremely encouraging for patients and for Bayer HealthCare. Therefore, we are planning to initiate our phase III program before the year’s end. We feel confident that we will be able to offer a safe and effective thrombosis prophylaxis that may be taken orally thus providing greater flexibility for patients,” said Wolfgang Plischke, president of Bayer HealthCare’s pharmaceuticals division.