Memory Pharmaceuticals reported 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.
The study evaluated MEM 1003 for the treatment of acute mania in bipolar disorder. Eighty-four subjects were randomized to receive MEM 1003 or a placebo for a 21-day 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 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 was achieved.
“We are obviously disappointed that MEM 1003 did not prove effective in the treatment of mania in our study,” said Stephen R. Murray, M.D., Ph.D., vp of clinical development. “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.”
The company’s shares prices opened Monday, March 5, at $1.95, down 38% from closing at $3.13 the previous Friday.