Teva GALA Phase III trial meets primary endpoint

14th June 2012 (Last Updated June 14th, 2012 18:30)

Teva Pharmaceutical Industries has reported positive top-line results from its Glatiramer Acetate Low-Frequency Administration (GALA) study, evaluating a new dose of glatiramer acetate injection (GA).

Teva

Teva Pharmaceutical Industries has reported positive top-line results from its Glatiramer Acetate Low-Frequency Administration (GALA) study, evaluating a new dose of glatiramer acetate injection (GA).

The trial evaluated the efficiency, 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 that the results of the study showed the potential of 40mg/1ml glatiramer acetate to offer patients an effective and safe treatment option with Copaxone (glatiramer acetate injection) 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 one-year double-blind placebo-controlled study, which randomised more than 1,400 patients at 155 multinational sites, showed that GA 40mg/1ml reduced disease activity, while maintaining a favourable safety and tolerability profile.

By significantly reducing the annualised 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.

There will be an ongoing open-label extension of the trial, followed by the initial 12-month, placebo-controlled phase, according to the company.

Reactions such as headaches and nasopharyngitis are commonly reported adversities from the injection, which were comparable to those observed in the placebo group. Teva plans to work with the health authorities to conclude the next steps.

Copaxone is known for the reduction of relapse frequency in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with MS. 


Image: Teva Factory in Har Hotzvim Jerusalem. Photo: courtesy of Wikipedia.