PALO ALTO, Calif., May 9 (UPI) -- Avicena said Tuesday its potential drug for Lou Gehrig's disease failed in trials to improve muscle strength and function.
Avicena said its phase 3 study of ALS-02, an investigational treatment for amyotrophic lateral sclerosis or Lou Gehrig's disease, "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, the company added that the drug candidate did appear to decrease mortality, based on comparison of data from the company's study with data from an earlier trial of ALS-02 done by the North East ALS Consortium.
"We are very interested in further exploring this trend toward decreased mortality," said Avicena Chief Executive Officer Belinda Tsao-Nivaggioli. "We are hopeful that together with (the Food and Drug Administration) we will be able to identify a clear path to market for ALS-02," she said.
Tsao-Nivaggioli added, "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 said it is currently compiling a meta-analysis of the recently completed phase 2 and 3 studies of ALS-02, along with past studies of the drug to determine with the FDA "the next development steps" for the treatment.
