Memory Pharmaceuticals Corp. has announced that it plans to conduct a clinical study of MEM 3454, the Company's lead nicotinic alpha-7 partial agonist, on two biomarkers of schizophrenia, P50 sensory gating and mismatch negativity, in patients with schizophrenia.
The biomarker study, and additional formulation and manufacturing activities for MEM 3454, will be funded by Roche, under the companies' collaboration for the development of nicotinic alpha-7 receptor agonists.
"This new study will greatly enhance our ability to measure and predict the efficacy of MEM 3454 and other compounds in the nicotinic alpha-7 receptor program," said Stephen Murray, MD, Ph.D, Chief Medical Officer of Memory Pharmaceuticals Corp. "The study should be underway this summer with data available by early 2009. The biomarker data, together with the results of our ongoing Phase 2a study in CIAS, will help with the design of later-stage trials in schizophrenia."
The biomarker study will enroll approximately 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be randomized to receive MEM 3454 and placebo in a 5-way cross-over design. Each subject will participate in 5 treatment periods.
During each period, subjects will receive single doses of 1 mg, 5 mg, 15 mg, or 50 mg of MEM 3454 or placebo, with a 4-day wash-out period between each treatment period. The primary objective of the trial is to study P50 sensory gating and mismatch negativity as potential efficacy biomarkers for nicotinic alpha-7 agonists, such as MEM 3454, in schizophrenia.
P50 sensory gating and mismatch negativity are two neurophysiological measurements that have been shown to be closely associated with nicotinic alpha-7 function and schizophrenia.