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Memory, Roche Expand Schizophrenia Development Program

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Memory Pharmaceuticals Corp. plans to conduct a clinical study of MEM 3454, the company’s lead nicotinic alpha-7 partial agonist, in patients with schizophrenia based on two biomarkers, P50 sensory gating and mismatch negativity. Development partner, Roche, will fund the biomarker study and additional formulation and manufacturing activities for MEM 3454 under the companies’ development collaboration for 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, M.D., Ph.D., chief medical officer of Memory Pharmaceuticals. “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 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 crossover design. 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.
   
In December 2007, Memory began a Phase IIa trial of MEM 3454 in schizophrenia as part of the development program. To maintain its license to MEM 3454, Roche would have to make an additional milestone payment to the company upon completion of the ongoing Phase IIa CIAS trial, which is expected to be completed in 4Q2008.

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