Baxter’s BAX 111 meets Ph III primary efficacy endpoint for VWF patients

US health care company Baxter International (NYSE:BAX) has released encouraging top-line results from a Phase III clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111, a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder.

The study of BAX 111, the first recombinant treatment in clinical development for this condition, met its primary efficacy endpoint, as all patients achieved pre-specified success in the on-demand treatment of bleeding events (100%, 22 of 22 patients who experienced bleeds in the trial).

''As the first recombinant, stand-alone treatment in development, BAX 111 has the potential to offer people with von Willebrand disease a new therapeutic option that may allow for greater precision and flexibility in managing the disease,'' said Bruce Ewenstein, vice president of clinical affairs, in Baxter BioScience. ''With these findings, we have taken another significant step forward as we continue to expand on our increasingly broad pipeline of potential treatments to improve outcomes for patients with a range of bleeding disorders,” he added.