New MS drug shows promise for Abbott
pharmafile | August 10, 2011 | News story | Research and Development, Sales and Marketing | Abbott, Avonex, Biogen, MS, gilenya
Biogen and Abbott’s multiple sclerosis drug daclizumab has performed well in a mid-stage trial, but two deaths marred the overall results.
The phase IIb study involved patients receiving daclizumab high-yield process (or DAC HYP), an injection which needs to be given just once every four weeks.
Biogen is a lead player in multiple sclerosis – Avonex leads the beta interferon market with $2.5 billion in sales, while Tysabri (natalizumab), is co-marketed with Elan and earned $1.2 billion last year.
Biogen and Abbott hope the greater convenience of the new injectable, twinned with good efficacy can help it maintain its dominant market position, but competition is hotting up.
The recent arrival of Novartis’ oral drug Gilenya (fingolimod) has changed the dynamic of the market, and two other rival oral drugs, Sanofi’s Lemtrada (alemtuzumab) and Teva’s laquinimod, are expected to be filed within the next year.
DAC HYP results
Top line results showed that patients had a significantly reduced annualised relapse rate of 54% in the 150 mg dose arm and 50% in the 300 mg dose arm, when compared to placebo.
The SELECT trial was designed to evaluate DAC HYP in people with relapsing-remitting multiple sclerosis (RRMS) over one year.
Adverse events were higher in the DAC HYP arm, and two deaths were registered from the SELECT study and from a second, ongoing dosing trial.
The companies said the deaths might be related to their drug, as a “contributory role for DAC HYP in these events could not be excluded”.
One death occurred in the SELECT study due to a complication of a psoas muscle abscess in a patient recovering from a serious skin adverse event. The second came from the ongoing dose blinded extension study SELECTION, and the firms believe this death was due to possible autoimmune hepatitis.
DAC HYP met key secondary endpoints for the 150 mg and 300 mg arms, respectively, providing a highly statistically significant reduction in the number of new gadolinium-enhancing lesions between weeks eight and twenty-four.
In addition to SELECT, the drug is also being studied in a phase III registrational clinical trial called DECIDE, which is currently enrolling patients.
DECIDE is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as a monotherapy, compared to Biogen’s own Avonex (interferon beta 1-a), over a two-to-three-year period.
Dr Doug Williams, Biogen’s executive VP of R&D said: “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,” he added.
Ben Adams
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