Memory: Preliminary phase 1 cognitive data for MEM 3454 shows significant results

By E. Janene Geiss

Philadelphia, Feb. 21 - Memory Pharmaceuticals Corp. said Tuesday that preliminary cognitive data from the multiple ascending dose study of the phase 1 clinical trial program of MEM 3454, the company's lead drug candidate in its Nicotinic Alpha-7 Agonist program, showed statistically significant results.

Cognition data generated in this study, using the Cognitive Drug Research battery, demonstrated that a 15 mg dose of MEM 3454 administered once daily for 13 days showed a statistically significant effect on the Quality of Episodic Secondary Memory, one of the study's primary efficacy variables, according to a company news release.

"The results from the research battery are promising, especially in light of the small sample size and importantly, support our belief that MEM 3454 has potential as a new therapeutic approach to treat important central nervous system disorders such as schizophrenia and Alzheimer's disease," David A. Lowe, chief scientific officer, said in the release.

"Based on the data we have to date, we are moving forward with a phase 2a trial that we plan to commence during the first half of this year," Lowe added.

The study was the final segment in a four-segment single-center phase 1 clinical trial program of MEM 3454 conducted in Toronto under Clinical Trial Applications that the company filed with Health Canada.

The study was a randomized, double-blind, placebo-controlled study of three doses of MEM 3454 (15 mg, 50 mg and 150 mg) and involved 48 healthy young male and female volunteers.

The primary purpose was to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of MEM 3454 in healthy volunteers.

A secondary objective of the study was to assess the cognitive effects of the doses tested, officials said.

After oral administration of 15 mg of MEM 3454 once per day for 13 days, there was a statistically significant effect on healthy volunteers.

This effect at 15 mg is supported by the company's preclinical work with MEM 3454, officials said.

The other doses administered in the study did not show a similarly statistically significant effect, although there was a trend toward efficacy at the 50 mg dose.

The company said it plans to release further results from the phase 1 clinical trial program of MEM 3454 during the second quarter of 2006.

Memory is a Montvale, N.J., biopharmaceutical company focused on developing innovative drugs for the treatment of debilitating central nervous system disorders such as Alzheimer's disease, schizophrenia, depression, bipolar disorder, vascular dementia, mild cognitive impairment, Parkinson's disease and memory impairments associated with aging.

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