Today Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) announced additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that DAC HYP, administered subcutaneously once every four weeks, met the trial's primary endpoint by significantly reducing the annualized relapse rate by 54 percent in the 150 mg dose group (p<0.0001) and 50 percent in the 300 mg dose group>th/sup> Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam.
“We continue to be very encouraged by the clinical profile for DAC HYP, particularly the annualized relapse rate and disability progression results that we have seen in the data from the SELECT study”
"These data from SELECT position DAC HYP as a potentially impactful new treatment option for multiple sclerosis (MS) with the convenience of a once-monthly subcutaneous injection, a first for patients," said Alfred Sandrock, M.D., Biogen Idec's Senior Vice President of Development. "We hope to see a similar effect on relapses and disability progression in the Phase 3 DECIDE trial, DAC HYP's second registrational trial, which is currently underway."
In SELECT, more than 90 percent of patients in the DAC HYP groups completed the study. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging (MRI). In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69%; 78%; p<0.0001). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%; p<0.0001). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%; p<0.0001).
"We continue to be very encouraged by the clinical profile for DAC HYP, particularly the annualized relapse rate and disability progression results that we have seen in the data from the SELECT study," said John M. Leonard, M.D., Abbott's Senior Vice President of Global Pharmaceutical Research & Development. "We are pleased that the Abbott-Biogen Idec collaboration continues to make excellent progress in advancing the development of a potential new MS therapy."
DAC HYP reduced the proportion of patients who relapsed by 55 percent in the 150 mg group (p<0.0001) and by 51 percent in the 300 mg group>
SELECT also investigated the effect of DAC HYP on disability progression as measured by the Expanded Disability Status Scale (EDSS) as a tertiary endpoint. Findings showed that DAC HYP reduced the risk of 12-week sustained disability progression at one year by 57 percent in the 150 mg dose group.
"Despite significant advances in the treatment of MS, there continues to be a need for additional treatment options for people with MS," said Dr. Gavin Giovannoni, M.D., Barts and The London School of Medicine and Dentistry, U.K. "DAC HYP's mechanism of action increases CD56Bright NK cells, which are thought to target abnormally activated immune cells that may play a role in MS without depleting the immune system. This mode of action, combined with the strong efficacy profile in SELECT and convenient dosing schedule of one subcutaneous injection per month, suggest that it could be a promising therapy for patients in need."
The overall incidence of adverse events (AEs) and treatment discontinuations were similar in all study groups. Serious adverse events (SAEs) over the course of the study, excluding MS relapse, occurred in six percent in the placebo group, seven percent in the 150 mg dose group and nine percent in the 300 mg dose group. Serious infections (2% versus 0%), serious cutaneous events (1% versus 0%) and liver function test abnormalities greater than five times the upper limit of normal (4% versus <1%) occurred more frequently in DAC HYP groups than in the placebo group. There was one death in SELECT due to a complication of a psoas muscle abscess in a patient recovering from a serious skin adverse event; a contributory role for DAC HYP could not be excluded.
The SELECT data was presented in a late-breaking platform presentation, called A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of daclizumab HYP monotherapy in relapsing-remitting multiple sclerosis: primary results of the SELECT trial, on Saturday, October 22, 2011.