MEM 1003 fails Ph IIa bipolar disorder trial

The USA's Memory Pharmaceuticals reported disappointing top-line data from a Phase IIa study of its drug candidate MEM 1003 in acute mania in bipolar disorder. An analysis of the primary and secondary outcome measures in the trial indicated that MEM 1003 did not prove effective for the treatment of bipolar mania.

The multicenter, double-blind, randomized, placebo-controlled study evaluated the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder. 84 subjects were randomized to receive MEM 1003 or placebo for a 21-day treatment period, which was followed by an optional open-label four-week therapy regimen. The primary outcome measure was a comparison of the percentage of subjects in the placebo and MEM 1003 treatment groups with at least 50% improvement from baseline in the Young Mania Rating Scale (YMRS) at 21 days. The secondary outcome measures were the mean change from baseline in the YMRS, the Modified Clinical Global Impression - Bipolar Scale and the Montgomery-Asberg Depression Rating Scale at 21 days. None of these outcome measures were achieved, Memory noted.

The firm said it was committed to finishing the ongoing Phase IIa studies of the drug in Alzheimer's disease, which is due to yield results in the fourth quarter, and noted that it is currently completing an evaluation of the bipolar disorder data.