Biogen Idec and Abbott have announced results from SELECT, a global, registrational Phase 2b clinical trial designed to evaluate the investigational compound Daclizumab high-yield process ( DAC HYP ) in people with relapsing-remitting multiple sclerosis ( RRMS ) over one year.
The results showed that DAC HYP, administered subcutaneously once every four weeks, significantly reduced annualized relapse rate by 54% in the 150 mg dose arm ( p<0.0001 ) and 50% in the 300 mg dose arm ( p=0.0002 ) compared to the placebo arm at one year.
DAC HYP met key secondary endpoints for the 150 mg and 300 mg arms, respectively, providing a highly statistically significant reduction in the cumulative number of new gadolinium-enhancing ( Gd+ ) lesions between weeks eight and 24 ( 69%; 78% ); 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.

The SELECT trial also investigated DAC HYP's effect 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 sustained disability progression at one year by 57% in the 150 mg dose arm and by 43% in the 300 mg dose arm compared to placebo.

In the SELECT trial, the overall incidence of adverse events and treatment discontinuations were similar in all study arms. 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 less than 1% ) occurred more frequently in DAC HYP-treated patients 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 and one in the ongoing dose blinded extension study ( SELECTION ) due to possible autoimmune hepatitis; a contributory role for DAC HYP in these events could not be excluded.

Daclizumab high-yield process ( DAC HYP ) is a subcutaneous formulation of Daclizumab and an investigational therapy for the treatment of relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis. DAC HYP is a humanized monoclonal antibody that binds to CD25, a receptor subunit that is expressed at high levels on T cells that are thought to become abnormally activated in autoimmune conditions, such as multiple sclerosis. Data from previous clinical trials showed that DAC HYP increases CD56bright NK cells, which target the activated immune cells that can play a key role in multiple sclerosis without causing general immune cell depletion.

Source: Biogen Idec, 2011

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