Lead scientists representing Biogen and AbbVie presented new data on clinical results from the Phase 3 study DECIDE on the compound ZINBRYTA TM at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain. The full results of the 2 to 3-year long Phase 3 study were also published in the New England Journal of Medicine (NEJM), in a manuscript entitled “Daclizumab HYP Versus Interferon Beta-1a in Relapsing Multiple Sclerosis”.
ZINBRYTA TM (daclizumab high-yield process) is a compound being developed by Biogen and AbbVie for the treatment of relapsing-remitting multiple sclerosis (RRMS). It consists of a humanized monoclonal antibody that binds to the receptor subunit CD25 of interleukin-2 (IL-2), highly expressed in immune T-cells. This type of immune cells is overly expressed in MS, so ZINBRYTA theoretically depletes the overly-activated cells and increases cells that regulate the immune response (NK cells). The study DECIDE was designed with the objective of comparing clinical results of subcutaneously-delivered ZINBRYTA (every four weeks) and the commonly used intramuscular injection (IM) of interferon beta-1a.
The results covered a range of clinical measures on MS disease activity, and showed that a greater percentage of patients treated with ZINBRYTA TM exhibited no evidence of clinical disease activity and disease-related lesions (24.6%) in comparison to IM-interferon beta-1a treated patients (14.2%). Furthermore, ZINBRYTA was shown to improve cognitive processing speed, reduce cognitive decline and decrease risk of 24-week disease progression.
A safety and tolerability profile for ZINBRYTA TM was also presented by the researchers at ECTRIMS. Researchers compiled and analyzed data from six clinical studies, including 2,236 RRMS patients treated with the drug. This sample included 888 patients treated for more than 3 years and 211 patients treated longer than 5 years. Data analyses showed that, when compared to interferon beta-1a treatment, cutaneous adverse events were more common in ZINBRYTA TM-treated patients (37% versus 19%). Importantly, the adverse events did not appear to increase over time in patients.
Dr. Gilmore O’Neil, M.D. and vice president of Multiple Sclerosis Research and Development at Biogen, highlighted the positive results in a press release, “These new analyses advance our understanding of ZINBRYTA and its ability to slow the progression of MS compared to a widely used, approved therapy. In addition, we are encouraged by the positive results of the analyses of ZINBRYTA on measures of cognitive function, which is also at risk as MS progresses.”