Teva reports top-line results from phase III MS trial
Monday, June 18, 2012
Teva Pharmaceutical, an Israel-based global pharmaceutical company, released positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) phase III trial showing that 40mg/1ml glatiramer acetate injection (GA) significantly reduced multiple sclerosis (MS) disease activity, while maintaining a favorable safety and tolerability profile.
The one-year randomized, double-blind placebo-controlled study recruited more than 1,400 patients with relapsing-remitting MS at 155 multinational sites. Subjects received 40mg/1ml GA administered subcutaneously three times a week or placebo. Results showed that GA 40mg/1ml met the study’s primary endpoint by significantly reducing the annualized relapse rate (ARR) by 34.4% compared to placebo (p<0.0001). Initial analysis of the data indicates that secondary clinical endpoints were achieved, with the exception of reduction in brain atrophy. Following the initial 12-month, placebo-controlled phase, there will be an ongoing open-label extension of the trial.
“We are pleased with the results of this study that show the potential of 40mg/1ml glatiramer acetate to offer patients an effective and safe treatment option with Copaxone using a more convenient dosing regimen” said Serge Stankovic, senior vice president of clinical research, global branded R&D, Teva Pharmaceutical. “We remain focused on the continued research and development of products aimed at improving the treatment experience for patients with MS.”
Further analyses of the GALA study data are ongoing, and detailed results will be presented to the scientific community in the near future. Teva plans to work with health authorities to determine next steps.
The most commonly reported adverse events in the study were injection site reactions, headaches and nasopharyngitis. The overall frequencies of adverse events were comparable to those observed in the placebo group.