Following Phase II Failure, Teva Drops Investigation Of Glatiramer For ALS
This article was originally published in The Pink Sheet Daily
Executive Summary
Compound fails to meet primary and secondary trial endpoints.
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Another setback for Teva's ALS pipeline as talampanel tanks in Phase II
Teva's selective AMPA antagonist talampanel failed to meet the primary endpoint in a Phase II trial in amyotrophic lateral sclerosis, ending its prospects. The May 17 announcement comes just over two years after Teva terminated its lead project in ALS, a higher-dose formulation of glatiramer, the active ingredient in Teva's multiple sclerosis therapy Copaxone, also after a Phase II failure (1"The Pink Sheet" DAILY, March 13, 2008). The Phase II ALSTAR trial of talampanel enrolled 559 ALS patients randomized to one of two doses of talampanel or placebo for 52 weeks to determine if the drug could reduce disease-related functional deterioration. Talampanel failed to show an effect on the change from baseline in the revised ALS Functional Rating Scale, the primary outcome measure, Teva reported, although the study did demonstrate the drug to be safe
Another setback for Teva's ALS pipeline as talampanel tanks in Phase II
Teva's selective AMPA antagonist talampanel failed to meet the primary endpoint in a Phase II trial in amyotrophic lateral sclerosis, ending its prospects. The May 17 announcement comes just over two years after Teva terminated its lead project in ALS, a higher-dose formulation of glatiramer, the active ingredient in Teva's multiple sclerosis therapy Copaxone, also after a Phase II failure (1"The Pink Sheet" DAILY, March 13, 2008). The Phase II ALSTAR trial of talampanel enrolled 559 ALS patients randomized to one of two doses of talampanel or placebo for 52 weeks to determine if the drug could reduce disease-related functional deterioration. Talampanel failed to show an effect on the change from baseline in the revised ALS Functional Rating Scale, the primary outcome measure, Teva reported, although the study did demonstrate the drug to be safe
High Copaxone Dose Fails To Show Superiority In MS, Teva Says
In Phase III, 40 mg dose did not reduce relapse rate in patients over the approved 20 mg strength.