The phase IIa trial evaluated the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder. The primary outcome measure was 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.
There were no serious adverse events reported in the MEM 1003 treatment group during the study, in contrast to three serious adverse events of worsening of mania reported in the placebo treatment group. The most commonly reported adverse events in the MEM 1003 treatment arm of the trial were headache, gastrointestinal effects and pruritus (or itching).
“We are obviously disappointed that MEM 1003 did not prove effective in the treatment of mania in our study,” said Stephen Murray, vice president 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.”
Memory Pharmaceuticals expects results from the phase IIa study of MEM 1003 in Alzheimer's in the fourth quarter of this year.