Axonyx Initiates Phase III Alzheimer's Disease Trial in Europe with Phenserine.

Business Editors/Health/Medical Writers

NEW YORK--(BUSINESS WIRE)--June 26, 2003

AXONYX INC. (NASDAQ: AXYX) today announced the initiation of a European Phase III clinical trial with its lead Alzheimer's disease drug, Phenserine. The Steering Committee and Investigator's Meeting, organized for June 27th and 28th in Munich, Germany, signals the start of the Phase III clinical trial and recruitment to this trial will commence following the meetings. This randomized placebo-controlled double-blind trial will evaluate the safety and efficacy of two different dosages of Phenserine in 375 mild to moderate Alzheimer's disease (AD) patients for a six-month period. Phenserine is an acetylcholinesterase and beta-APP inhibitor that is being developed by Axonyx for the treatment of mild to moderate AD patients.

This Phase III trial is intended to substantiate the positive safety and efficacy results seen in an earlier 12-week Phase II study in mild to moderate AD patients. Patients in this trial will undergo testing with the standard memory and cognition tests recommended by the United States FDA and European regulatory authorities. Three hundred and seventy-five patients suffering from mild to moderate AD will be recruited from various clinical sites in Europe.

Phenserine is currently undergoing clinical testing in a Phase IIB study designed to evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein and beta-amyloid in the plasma and cerebrospinal fluid of mild to moderate AD patients. The presence of toxic beta-amyloid in the brains of AD patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD.

"The very few treatment options available to physicians for Alzheimer's patients and Phenserine's unique ability to improve memory as well as potentially slow disease progression has generated a lot of interest," stated Gosse B. Bruinsma, M.D., Chief Operating Officer of Axonyx. "It is gratifying to see the many enthusiastic investigators and their trial staff coming together for this important meeting."

About Axonyx

Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds and new technologies useful in the diagnosis and treatment of Alzheimer's disease, human memory disorders and prion-based illnesses such as Mad Cow Disease.

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 and Phase III clinical trials, 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 the efficacy data from the Phase IIB clinical trial will be able to be used in the Phase III trial efficacy data, 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.