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Press Release Source: Axonyx Inc.
Axonyx Reports Statistically Significant Result for Phenserine in Alzheimer's Disease
Tuesday November 29, 8:30 am ET
Additional Analysis Results from Curtailed Phase III Clinical Trials
NEW YORK--(BUSINESS WIRE)--Nov. 29, 2005--Axonyx Inc. (NASDAQ: AXYX - News) reports today the results of an additional analysis of a subgroup of patients from its two curtailed Phase III clinical trials (AX-CL-09/010) with Phenserine, in development for mild to moderate Alzheimer's disease (AD). The subgroup of patients, who received Phenserine 15mg twice daily, demonstrated a statistically significant benefit over placebo as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), when treated for more than 12 weeks. Additionally, this subgroup showed a positive trend towards improvement in the Clinical Interview Based Impression of Change (CIBIC+) test, which approached statistical significance. There were no unexpected safety or tolerability concerns associated with Phenserine treatment. This analysis was undertaken in addition to the previously announced results of the primary pre-defined statistical analysis.
While additional clinical trials would be required to further confirm the results of this additional analysis, the Company believes that they support its stated position that higher doses of Phenserine could potentially be efficacious in treating the signs and symptoms of mild to moderate AD in future potential Phase III trials of 26 weeks duration.
On September 20, 2005, the Company announced the top line results from its primary efficacy analysis of all patients that participated in the curtailed Phase III clinical trials; this analysis did not demonstrate a statistically significant benefit associated with Phenserine over placebo after 12 weeks of treatment in either the ADAS-cog or CIBIC+, the primary efficacy endpoints for the study. At that time, the Company indicated that it would continue to evaluate the Phenserine program. On November 7, 2005, the Company indicated it would not commit further resources to the development of Phenserine and would seek a partner for the compound.
This additional analysis was recently completed as part of the program to identify a partner for the further development of Phenserine. The analysis included 182 patients who received Phenserine treatment or placebo for more than 12 weeks and up to 26 weeks of treatment. The statistically significant benefit was based on the ADAS-cog test; one of the FDA approved measurements of efficacy in Alzheimer's disease clinical trials. The improvement in the CIBIC+ test, another approved efficacy endpoint, for the 15mg twice daily group approached statistical significance compared to the placebo group. The patients who received Phenserine 10mg twice daily did not show a statistically significant benefit compared to placebo.
Details of the secondary analysis results are provided in the chart below. For the ADAS-cog, more negative values indicate greater improvement of cognition. For CIBIC+ lower values indicate greater improvement.
Mean Changes from Baseline to Last Visit in the Post Week 12 Patient
Subgroup
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15-mg Mean Difference
Endpoint Twice Daily Placebo 15mg vs. Placebo P - value(c)
n = 54 n = 66 (+/-95% Confidence Intervals)
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ADAS-cog(a) -3.18 -0.66 -2.52 (-4.92 to -0.12) 0.0296
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CIBIC+(b) 3.59 3.95 -0.36 (-0.76 to 0.04) 0.0568
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a) Ranked ANCOVA model with centre and baseline covariates.
b) Cochran-Mantel-Haenzsel test incorporating rank scores.
c) Statistical significance is defined as a P value of 0.05 or
less.
Phenserine is a highly selective acetylcholinesterase inhibitor (AChE-I) that breaks down a neurotransmitter in the brain important in memory and cognition. Unlike other AChE-I's which only suppress the activity of the enzyme, Phenserine has been shown to have two mechanisms of action: (1) the inhibition of the AChE enzyme, and (2) in preclinical studies the inhibition of the synthesis of A beta, the protein in the brain that is thought by many to be a potential cause of Alzheimer's disease and its progression.
About Axonyx
Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds for the treatment of Central Nervous System disorders. The Company currently has three compounds in development for Alzheimer's disease, namely Phenserine - a potential symptomatic and disease progression treatment of mild to moderate Alzheimer's Disease (AD), Posiphen(TM) - a potential disease progression treatment for AD now in Phase I, and BisNorCymcerine (BNC) - a potential symptomatic treatment of severe AD now in pre-Investigational New Drug (IND) stage.
This press release may contain forward-looking statements or predictions. These statements represent our judgment to date, and are subject to risks and uncertainties that could materially affect the Company, including those risks and uncertainties described in the documents Axonyx files from time to time with the SEC, specifically Axonyx's annual report on Form 10-K. Specifically, with respect to our drug candidates Phenserine, Posiphen(TM) and BisNorCymcerine, Axonyx cannot assure that: any preclinical studies or clinical trials, whether ongoing or conducted in the future, will prove successful, and if successful, that the results can be replicated; safety and efficacy profiles of any of its drug candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; pre-clinical results related to cognition and the regulation of beta-APP will be substantiated by ongoing or future clinical trials, if any, or that any of its drug candidates will be able to improve the signs or symptoms of their respective clinical indication or slow the progression of Alzheimer's disease; any of its drug candidates will support an NDA filing or its equivalent, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; or that Axonyx will have or obtain the necessary financing to support its drug development programs. Axonyx cannot assure that it will be successful with regard to identifying a (sub-) licensing partner for any of its compounds. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contact:
Axonyx Inc., New York
S. Colin Neill, 212-645-7704
www.axonyx.com
OR
Media:
Stephanie Carrington, 646-536-7017
scarrington@theruthgroup.com
