Teva Pharmaceutical Industries Ltd. announced final results from the global phase II GoALS trial. The study was designed to assess the safety, tolerability and efficacy of glatiramer acetate (GA) 40 mg, given once daily as a subcutaneous injection, in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis (ALS) patients. Results show that GA 40mg was safe and well-tolerated in ALS patients; however, the study's primary and secondary endpoints were not met.

Glatiramer acetate is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS).

"Despite our hopes and desires, similar to other drug candidates for the treatment of ALS, GA 40 mg did not prove beneficial for ALS patients but was shown to be safe and well tolerated," said Professor Vincent Meininger from Hopital de la Salpetriere, Paris, France, and principal investigator of the study, "The academic community caring for ALS patients, is very pleased with Teva's commitment to continue developing innovative treatment options such as Talampanel for such a devastating disease".

The multinational, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase II study was conducted in 13 centres located in Israel, Belgium, France, Germany, Italy and the United Kingdom and included 366 patients with ALS. Patients received either GA 40 mg or placebo as a subcutaneous injection and continued treatment for 52 weeks. The primary outcome measure was change in ALS ALSFRS-R score. The secondary outcome measure was increased survival. The study results show that GA 40mg is not effective in the treatment of ALS; however, the drug was safe and very well tolerated.