Biogen And Abbvie Report Positive Phase 3 Data For Daclizumab In MS

Biogen Idec and collaborator Abbvie reported positive and topline results from a Phase III study investigating daclizumab high-yield process (DAC HYP) in multiple sclerosis (MS).

Daclizumab high yield process is a novel form of humanized monoclonal antibody that binds to CD25, a receptor subunit expressed at high levels on T-cells known to become abnormally activated in MS. DAC HYP works to modulate IL-2 signaling while avoiding general depletion of immune cells. The drug is considered to increase natural killer cells that help control the immune system while decreasing pro-inflammatory lymphoid tissue inducer cells and abnormally-activated T-cells.

The 2-3 year, global, multi-center, double blind, randomized Phase III DECIDE study evaluated DAC HYP for superiority over treatment with IFN β-1a intramuscular injection. The trial met its primary endpoint of reduction in annualized relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis (RRMS). DAC HYP also demonstrated superiority on the trial’s first secondary endpoint, achieving significant reduction on the number of new or newly enlarging T2-hyperintense lesions at week 96 compared to IFN β-1a.

Gilmore O’Neill, vice president of Global Neurology Clinical Development at Biogen Idec, said, “The results of the DECIDE study are compelling, with DAC HYP demonstrating robust efficacy compared to a current standard of MS care. As a potential once-monthly therapy with a novel mechanism of action, we believe that, if approved, DAC HYP will be an important treatment option for people living with MS.”

Michael Severino, executive vice president of R&D and chief scientific officer at AbbVie, said, “The positive results in the DECIDE study represent achievement of an important milestone in the development of DAC HYP as a potential new treatment option for MS patients.” Severino also said that Biogen and Abbvie plan to discuss with regulatory authorities to identify the best times for regulatory filing for DAC HYP. The companies will also present detailed DECIDE trial results at an upcoming medical conference.