Teva Pharmaceutical Industries Ltd Announces Results From GALA Phase III Trial Evaluating New Dosage For Glatiramer Acetate Given Three Times Weekly For Relapsing Remitting Multiple Sclerosis

Teva Pharmaceutical Industries Ltd announced positive top-line results from the GALA (Glatiramer Acetate Low-Frequency Administration) Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection (GA) administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis (RRMS) patients. Study results showed that GA 40 mg/1 ml significantly reduced 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 at 155 multinational sites. Results showed that GA 40 mg/1 ml 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. 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.