Teva Pharmaceutical Industries Ltd. and Active Biotech AB has announced that data from a 36-week, randomised, doubleblind, placebo-controlled phase IIb study demonstrated that an oral 0.6 mg dose of laquinimod given daily significantly reduced magnetic resonance imaging (MRI) disease activity by 38 per cent in RRMS patients and was well tolerated. In addition, there was a favourable trend towards reducing annual relapse rates, the number of relapse-free patients and time to first relapse compared with placebo.
Treatment with a 0.3 mg dose showed no statistical significant difference compared with placebo. "Current RRMS options are effective for the treatment of the disease, but an oral therapy such as laquinimod would represent a milestone for patients as it would provide them with a completely unique, non-invasive method of drug delivery," said Giancarlo Comi, MD, director of department of neurology and institute of experimental neurology, Universita Vita-Salute, San Raffaele, Milan, Italy.
"Preliminary studies have already demonstrated the positive effect of laquinimod versus placebo, but these new data confirmed that a higher dose was even more effective and remained well tolerated." The 36-week study evaluated the effect of oral daily 0.3 and 0.6 mg doses of laquinimod on MRI-monitored disease activity in patients with RRMS. The majority of the patients who participated in the study continued treatment with laquinimod in an ongoing, blinded 9 month extension study. This extension study is followed by an open label study where patients will receive 0.6 mg laquinimod for an additional 24 months.
"The results of this study, which once again demonstrate the efficacy and tolerability of once-daily oral laquinimod, are very exciting for the MS community both patients and researchers," said Shlomo Yanai, president and CEO of Teva Pharmaceutical Industries Ltd. "Teva will soon initiate phase III studies to confirm oral laquinimod's therapeutic benefits, and we expect to begin enrolment of the trial later this year."