Generic drugs maker Teva Pharmaceutical Industries Limited (TEVA) on Thursday said results from its GALA (Glatiramer Acetate Low-Frequency Administration) Phase III clinical trial showed that glatiramer acetate injection 40 mg/1 ml significantly reduced disease activity in relapsing-remitting multiple sclerosis patients, while maintaining a favorable safety and tolerability profile.
The trial assessed the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection, or GA, administered three times a week compared to placebo in these patients.
The 40 mg/1 ml dose is higher than the currently marketed 20 mg/1 ml daily Copaxone (glatiramer acetate injection). The primary endpoint of the study was the total number of confirmed relapses during a 12-month, placebo-controlled phase.
Serge Stankovic, Senior Vice President of Clinical Research, Global Branded R&D, Teva, said, "We are pleased with the results of this study that show the potential of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe treatment option with COPAXONE using a more convenient dosing regimen."
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 or ARR by 34.4 percent compared to placebo.
Initial analysis of the data indicated that secondary clinical endpoints, except reduction in brain atrophy, were achieved. After the initial 12-month, placebo-controlled phase, there will be an ongoing open-label extension of the trial.
The most commonly reported adverse events in the study were injection site reactions, headaches and nasopharyngitis. The frequencies of adverse events were comparable to those observed in the placebo arm.
Teva said further analyses of the study data are in progress. The company expects to present the detailed results to the scientific community in the near future. Teva plans to work with health authorities to decide next steps.
TEVA, which closed at $38.54 on Wednesday, is up by half a percent in pre-market trading.
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