The studies will now begin following the successful conclusion of a second phase II study and the outcome of discussions with the FDA and the European Medicines Agency.
The companies are to commence two global phase III trials of laquinimod during this year. The phase III trials will take place in centers in the US, Europe, and other locations worldwide, to further confirm the results of the phase II trials.
“We are extremely excited about initiating the phase III clinical program for oral laquinimod, as we believe laquinimod is a potential new and convenient treatment option for MS patients,” said Shlomo Yanai, president and CEO of Teva. “The accelerated development of oral laquinimod is part of our commitment to MS patients to develop additional improved therapies that combine superior efficacy and excellent safety.”
Data from the 36-week, placebo-controlled phase IIb trial demonstrated that an oral 0.6 mg dose of laquinimod given daily significantly reduced disease activity, as measured by magnetic resonance imaging, by 40% in RRMS patients and was well tolerated.
In addition, there was a favorable trend towards reducing annual relapse rates, the number of relapse-free patients and time to first relapse compared with placebo. Treatment with both 0.3 and 0.6 mg doses of laquinimod were well tolerated with only some transient and dose-dependent increases in liver enzymes.
MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.