(Posted By: Josi Creek)
Biogen Idec and Abbott today announced enrollment of the first patient in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX(R)) in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The trial, called DECIDE, will investigate a subcutaneous formulation of daclizumab intended for monthly administration, which has the potential to provide a new immunomodulatory approach for treating MS. Under the terms of the collaboration agreement, Biogen Idec will make a $30 million milestone payment to Abbott. This payment is due upon enrollment of the first patient in the DECIDE trial.
"Despite significant advances in MS therapy, many patients continue to experience disease activity. The MS community is eager for new treatment approaches," said Ludwig Kappos, M.D., Head, MS-Research Group, University Hospital, Basel, Switzerland, and lead investigator for the study. "As shown in previous studies, daclizumab appears to selectively target immune cells that are thought to become activated in MS and cause damage to the central nervous system."
DECIDE is a global Phase III, randomized, double-blind, active-comparator study expected to enroll approximately 1,500 RRMS patients in 28 countries. The trial will investigate a subcutaneous formulation of daclizumab intended for once-monthly administration as a monotherapy compared to treatment with interferon beta 1-a, one of the most common treatments for MS. Daclizumab is also being investigated in the ongoing Phase IIb registration-enabling SELECT trial, which is evaluating the efficacy and safety of monthly subcutaneous doses of either 150 mg or 300 mg of daclizumab monotherapy.
Labels: Clinical Trials, Daclizumab, Study
