FDAnews
www.fdanews.com/articles/62356-memory-initiates-study-of-mem-1003-in-bipolar-disorder

MEMORY INITIATES STUDY OF MEM 1003 IN BIPOLAR DISORDER

September 8, 2006

Memory Pharmaceuticals has begun dosing in a Phase IIa trial of MEM 1003 in patients with acute mania in bipolar disorder. The company is conducting the trial as part of its agreement with The Stanley Medical Research Institute, which is providing funding support for this trial.

The multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder. Approximately 60 subjects in the United States will be enrolled in the trial and randomized to receive MEM 1003 or placebo for a 21-day treatment period, which will be followed by an optional open-label four-week treatment period. Subjects in the MEM 1003 group will receive 60 mg of the drug twice a day, with up to two dose escalations, from 60 to 120 mg twice a day on the second day and from 120 to 180 mg twice a day on the third day. The primary outcome measure of the trial is the change in the Young Mania Rating Scale at 21 days.

MEM 1003 is a neuronal L-type calcium channel modulator that Memory is developing for the treatment of Alzheimer's disease and bipolar disorder. By blocking L-type calcium channels, MEM 1003 may regulate the flow of calcium and reestablish normal levels of calcium, which may correct or prevent the severe mood swings that characterize bipolar disorder.