PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) announced positive top-line results from the Glatiramer Acetate Low-Frequency Administration or GALA Phase III trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection or GA administered subcutaneously three times a week compared with placebo in relapsing-remitting multiple sclerosis or RRMS patients. The trial results demonstrated 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 over 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 by 34.4 percent compared to placebo.
Initial analysis of the data shows that secondary endpoints were achieved, with the exception of reduction in brain atrophy. Following the initial 12-month, placebo-controlled phase, there would be an ongoing open-label extension of the trial. Teva said it intends to work with health authorities to determine next steps.
Copyright RTT News/dpa-AFX