Study data showed no statistically significant difference between ALS-02 5g per day and placebo with regard to the study’s primary and secondary endpoints, which consisted of 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, the analysis demonstrated a positive trend toward decreased mortality in subjects receiving the compound. The compound was also found to be safe and well tolerated by patients.
“We are hopeful that together with FDA we will be able to identify a clear path to market for ALS-02,” stated Dr Belinda Tsao-Nivaggioli, chief executive officer of Avicena. “It is important to note that the one currently approved treatment for patients suffering from ALS offers only limited, short-term survival benefit and has not demonstrated benefit in regard to measures of muscle strength and neurological function.”
Avicena’s phase III study of ALS-02 was a multi-center, double-blind, placebo-controlled, randomized trial designed to evaluate the safety and efficacy of the compound at a dose of 5g per day for nine months.