AXYX Axonyx

Axonyx Inc. (NASDAQ: AXYX) announced today the following updates to its clinical development program and strategic initiatives. These will be reviewed by Gosse Bruinsma, MD, President and CEO of Axonyx Inc. at the Rodman and Renshaw 7th Annual Healthcare Conference at the New York Palace Hotel, New York, NY. The Axonyx presentation is scheduled for 8:40 a.m. Eastern Time on Tuesday, November 8, 2005 and will be web cast live on the company's website. CLINICAL DEVELOPMENT PROGRAM STATUS Phenserine Axonyx has now evaluated its entire Phenserine development program, including the results from the first Phase III trial announced in February and March 2005, the result of the curtailed and combined analysis of the second and third Phase III trials that was reported in September 2005 and the interim analyses of the beta amyloid trial announced in March and July 2005 as well as recent additional patient data. The Company has determined that it will not commit further resources to the development of Phenserine. As previously reported, none of the trials achieved statistical significance for the primary end points, however, positive signals were observed in all the Phenserine clinical trials to date, including the interim analyses of the Phase IIb beta amyloid trial. The results of this trial to date appear to show a difference between Phenserine 15mg and placebo on the levels of beta amyloid 1-42 (A beta 1-42). The magnitude of this difference and the variability of these data show that a larger investigation than planned would be needed to demonstrate a statistically significant effect. The Company believes that a re-formulated Phenserine to achieve potentially higher drug exposure to the patient may improve the efficacy profile and potential amyloid lowering effects. The clinical trials to date on Phenserine, including extensive preclinical studies, have provided the Company with a comprehensive set of data. The Company plans on utilizing this data set in a marketing package for potential licensees. Axonyx' goal is to identify a partner that is able and willing to commit the necessary financial resources to the compound's further development. Axonyx will not incur any additional development expenses for Phenserine beyond those expenses needed to close the ongoing activities in an orderly fashion. Posiphen(TM) Posiphen has been shown to lower beta-amyloid precursor protein (beta -APP) levels in pre-clinical studies. The primary mechanism of action results in a dose dependent reduction of beta amyloid, which may result in slowing AD progression. The initial pre-clinical side effect rates potentially allow for higher clinical doses. On August 1, 2005 the Company announced that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application allowing Phase I clinical testing of Posiphen. The first Phase I clinical study commenced in August 2005 and will primarily evaluate the safety of Posiphen in healthy volunteers. BisNorCymserine BisNorCymserine (BNC) is a highly selective butyrylcholinesterase inhibitor. Butyrylcholinesterase is found in high concentration in the plaques taken from individuals who have died from AD. Butyrylcholinesterase appears to have an increasing role with advancing Alzheimer's disease and its primary mechanism of action results in a dose dependent reduction of Acetylcholine. The initial pre-clinical side effect rate potentially allows higher clinical doses. A secondary mechanism of action is associated with dose dependent reductions of beta-APP and A beta. BNC, the lead compound from our butyrylcholinesterase family, is currently in full pre-IND development. Axonyx plans an IND submission in the first quarter of 2006 followed by the initiation of Phase I clinical studies in first quarter 2006. STRATEGIC INITIATIVES The Company intends to use its financial resources, previously allocated to the Phenserine program, to expand its pipeline. Current activities include screening and evaluation of companies, potential compounds and products to determine their strengths and commercial potential in addition to their strategic fit with the Company and its therapeutic focus. Axonyx is primarily targeting opportunities in the CNS area, but other therapeutic areas may also be considered. 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 BisNorCymserine (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 BisNorCymserine, 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, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; Axonyx will be able to successfully out-license any of its drug candidates; Axonyx will be able to successfully in-license any additional compounds; or that Axonyx will have or obtain the necessary financing to support its drug development programs. 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.