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news.Trophos' phase 3 study of olesoxime in Amyotrophic Lateral Sclerosis (ALS) patients did not demonstrate a significant increase in survival, as compared to placebo in patients receiving riluzole (Rilutek).
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The 18-month randomized, parallel group, double-blind, placebo-controlled trial conducted in 512 ALS patients evaluated the efficacy and safety of olesoxime against placebo in patients treated with riluzole.
Olesoxime was dosed orally at 330 mg once-a-day and the data showed that Olesoxime did not demonstrate significant benefit on the primary endpoint of survival after 18 months of treatment over that of riluzole.
The drug candidate was, however, very well tolerated with a side effect profile similar to riluzole plus placebo.
Following the demonstration of data, Actelion has informed Trophos of its decision to not exercise its exclusive option under the July 2010 Acquisition Option Agreement between the two companies.