AVICENA ANNOUNCES ALS TRIAL RESULTS
The Avicena Group has announced the results of a Phase III trial of its drug candidate, ALS-02, for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
Study data showed no statistically significant difference between ALS-02 (five grams per day) and placebo with regard to the study's primary and secondary endpoints (various measures of muscle strength, muscle fatigue and functional scores). However, in a separate analysis when mortality data was combined and analyzed with mortality data from a second study of ALS-02 previously conducted by the North East ALS Consortium (NEALS), the analysis demonstrated a positive trend toward decreased mortality in subjects receiving ALS-02. The compound was also found to be safe and well-tolerated by patients.