Biogen Idec (BIIB - Free Report) and Abbott Labs (ABT - Free Report) recently presented positive top-line data on their multiple sclerosis candidate, daclizumab. Biogen and Abbott Labs presented data from a phase IIb study – SELECT.
The global, randomized, double-blind, placebo-controlled, one-year, dose-ranging study was conducted to evaluate the safety and efficacy of daclizumab in 600 patients with relapsing-remitting multiple sclerosis (RRMS).
Two doses (150 mg or 300 mg every four weeks) of daclizumab were evaluated. Results showed that daclizumab reduced the annualized relapse rate by 54% in the 150 mg dose and 50% in the 300 mg dose arm compared to placebo.
Key secondary endpoints were also achieved by the candidate. The study also investigated daclizumab’s effect on disability progression as measured by the expanded disability status scale (EDSS) as a tertiary endpoint. Results showed that daclizumab reduced the risk of sustained disability progression at one year by 57% and 43% in the 150 mg and 300 mg dose arms, respectively. Biogen and Abbott Labs are currently analyzing the data further and expect to present detailed results at an upcoming medical meeting.
While the overall efficacy data is encouraging, there could be some concern regarding the safety profile of the candidate. Serious infections (2% versus 0%), serious cutaneous events (1% versus 0%) and liver function test abnormalities more than five times the upper limit of normal (4% versus <1%) were more frequent in the daclizumab arm compared to placebo.
Daclizumab is currently in another registrational study – DECIDE. The phase III study is evaluating the efficacy and safety of once-monthly daclizumab as a monotherapy compared to interferon beta 1-a therapy over two to three years of treatment.
We currently have Neutral recommendations on both Biogen and Abbott Labs.