Biogen Idec and its partner Abbott Labs have taken the wraps off the top-line data from a Phase IIb study of daclizumab, touting some promising results for the once-monthly treatment of multiple sclerosis as they push ahead with an ambitious late-stage program. Researchers said that the 150-mg dose arm demonstrated a 54% reduction in the annualized relapse rate, with "highly statistically significant" data recorded on secondary endpoints.
The news marks another upbeat turn of events for the new executive team running Biogen Idec, which has been buoyed by promising data on key programs. And it's a big plus for Abbott as well, which acquired Facet and the big stake in daclizumab for $450 million last year. The companies recruited 600 patients for the study.
Researchers studied two doses injected once every four weeks in Phase IIb, with the 150-mg arm reporting better results on the primary endpoint than the 300-mg group. Investigators also noted the "cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69% (for 150 mg); 78% (300 mg); in the number of new or newly enlarging T2 hyperintense lesions at one year (70%; 79%); and in the reduction in the proportion of patients who relapsed (55%; 51%). DAC HYP also showed a trend toward improvement in quality of life measures at one year."
Doug Williams, Biogen Idec's EVP of R&D, expressed enthusiasm about the results. "The exciting results for DAC HYP, along with previous clinical data, support our continued investigation of this candidate as a promising new approach to treating multiple sclerosis," he said in a statement. "DAC HYP's convenient once-monthly, subcutaneous administration, combined with a strong efficacy profile, suggest that it may provide an attractive option for MS patients. We hope to confirm the results of SELECT in our second registrational trial, DECIDE."
Daclizumab is an antibody which binds to CD25, a receptor found on T cells that are believed to be abnormally activated in autoimmune conditions, such as MS.
- here's the release