Teva Pharmaceutical Industries has reported that the Glatiramer Acetate Low-Frequency Administration (GALA) study evaluating a new dose of glatiramer acetate injection (GA) met its primary endpoint.
The Phase III trial evaluated the efficacy, safety and tolerability of 40mg/1ml GA administered subcutaneously three times a week compared to placebo in relapsing-remitting multiple sclerosis (RRMS) patients.
Teva Pharmaceutical Industries Global Branded R&D, senior vice president of clinical research, Serge Stankovic said the results of the study showed the potential of 40mg/1ml glatiramer acetate to offer patients an effective and safe treatment option with Copaxone using a more convenient dosing regimen.
"We remain focused on the continued research and development of products aimed at improving the treatment experience for patients with MS," Stankovic added.
The double-blind placebo-controlled study, which randomized more than 1,400 patients at 155 multinational sites, showed that GA 40mg/1ml reduced disease activity, while maintaining a favorable safety and tolerability profile.
By significantly reducing the annualized relapse rate by 34.4% compared to placebo (p<0.0001), the GA 40mg/1ml met the study's primary endpoint.
Initial analysis of the data specifies that secondary clinical endpoints were achieved, with the exception of reduction in brain atrophy.
