Axonyx Announces Completion of All Treatment Periods of Phase III Trial with Phenserine for Alzheimer's Disease; Axonyx on Target to Release Results First Quarter 2005.

NEW YORK -- AXONYX INC. (NASDAQ: AXYX) announced today the completion of the last 6-month patient treatment period in its Phase III double-blind placebo controlled clinical trial with Phenserine for Alzheimer's disease (AD). Axonyx initiated this Phase III trial in June 2003, and the last recruited patients have now successfully completed the study's 6-month treatment period; this puts Axonyx on target to announce the study's results by the end of March 2005.

More than 375 mild-to-moderate AD patients were randomly assigned to receive either Phenserine 15mg twice daily, or Phenserine 10mg twice daily, or placebo. Patients were tested with the standard memory and cognition tests that are the required efficacy endpoints by the United States FDA and European regulatory authorities.

The Company will spend the next several weeks carefully ensuring that the database is accurate and complete. Once this has been accomplished, the database will be locked and the statistical analyses of the efficacy and safety endpoints will follow.

Phenserine is a dual action acetylcholinesterase and beta-APP inhibitor that is being developed by Axonyx for the treatment of mild-to-moderate AD patients. Two additional Phase III clinical trials were initiated in the latter half of 2004.

Phenserine is also currently undergoing clinical testing in a Phase IIB (the so-called "beta-amyloid") trial that will evaluate Phenserine's ability to lower levels of beta-amyloid precursor protein (B-APP) and beta-amyloid (AB) in the plasma and cerebrospinal fluid (CSF) of mild-to-moderate AD patients following 6-months of treatment. It is believed that AB may be an important cause of AD and its reduction may lead to a slowing of disease progression. An interim analysis of this study is planned to take place in the first quarter of 2005.

"The clinical investigators and the Axonyx clinical operations team have worked diligently and conscientiously to bring our trial to this important point," stated Gosse B. Bruinsma, M.D., President & Chief Operating Officer of Axonyx Inc. "I am confident that these efforts will continue as we work through the final stage and analyze the results of this key trial."

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.

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. Axonyx cannot assure that the Phase IIb and/or the Phase III clinical trial, or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II trial will remain the same in the Phase IIb clinical trial, or future clinical trials, if any, that the preclinical results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIb clinical trial and that Phenserine will be able to slow the progression of Alzheimer's disease ,that the Phase IIb clinical trial data will differentiate Phenserine from the currently marketed drugs, that the efficacy results of the Phase III trial will prove pivotal, that Axonyx will obtain the necessary financing to complete the Phase III Phenserine trials, that the Company's development work on Phenserine will support an NDA filing, that the results of the Phase III trials will allow Phenserine to be approved by the FDA, that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize marketing opportunities for, Phenserine, or that Axonyx will be able to advance any other potential memory enhancing compound toward IND status. 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.