MEMORY PHARMA'S DRUG FAILS IN MANIA TRIAL

Memory Pharmaceuticals announced top-line data from the Phase IIa study of 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. But the drug was safe and generally well-tolerated in the study.

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. Eighty-four 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 treatment period.

The primary outcome measure was a comparison of the percentage of subjects in the placebo and MEM 1003 treatment groups with at least a 50 percent improvement from baseline in the Young Mania Rating Scale (YMRS) at 21 days. The secondary outcome measures were the mean changes 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.

"We are obviously disappointed that MEM 1003 did not prove effective in the treatment of mania in our study," Stephen Murray, vice president of clinical development, said. "However, the target symptoms and the nature of the assessments in our ongoing Phase IIa study in Alzheimer's disease are very different from those in this mania study, and we do not believe that the negative results in this study are predictive of the effects of MEM 1003 in Alzheimer's disease."