The study, known as the Choice trial, is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active multiple sclerosis (MS). The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.
Mark McCamish, chief medical officer, PDL BioPharma, said: “We are very pleased to see positive results from the CHOICE study, the first randomized trial of daclizumab in patients with relapsing MS. We recognize how monoclonal antibodies have changed modern medicine and see great potential in their ability to treat serious diseases, including cancer and select immunological diseases such as MS.”
Alfred Sandrock, senior vice president, neurology R&D, Biogen Idec, said: “Daclizumab represents an exciting opportunity within our growing MS portfolio. MS is a complex disease that requires an arsenal of treatment options for patients. We look forward to advancing the daclizumab development program and initiating the SELECT trial by the end of the year.”