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news.Novartis has reported the positive clinical data from its Phase III 2309 study, evaluating Gilenya (fingolimod) as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS).
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Gilenya, licensed from Mitsubishi Tanabe Pharma is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
The two-year placebo-controlled parallel-group multi-centre Phase III 2309 clinical trial included 1083 patients, and were randomised 1:1:1 to fingolimod 1.25 mg, fingolimod 0.5 mg or placebo, to demonstrate the efficacy and safety of Gilenya in patients with RRMS.
The drug candidate has demonstrated 48% reduction in annualised relapse rates (ARR) at 24 months, a 17% and 28% reduction in three-month and six-month confirmed disability progression, respectively, and 34% reduction of six-month confirmed disability progression over placebo.
The two earlier Gilenya studies- a two-year placebo-controlled trial and a one-year head-to-head trial against interferon-beta-1a (IM) also showed a 54% and a 52% relative reduction in ARR, respectively.
Novartis Pharma Pharmaceuticals Division head David Epstein said the Phase III study confirms the efficacy of Gilenya across key measures, such as reductions in annualised relapse rate and reductions in brain volume loss.
"With more than 20,000 patient years of fingolimod exposure to date, Gilenya continues to demonstrate its value to patients and the MS community. We are looking forward to presenting the full data to the clinical community at a scientific congress next year," Epstein added.