Axonyx Announces Phenserine Clinical Program for 2003.

Business Editors

NEW YORK--(BUSINESS WIRE)--Jan. 29, 2003

Axonyx Inc. (NASDAQ:AXYX) today announced its 2003 clinical development plans for Phenserine, the Company's lead drug candidate for the treatment of mild to moderate Alzheimer's disease.

These plans are to be outlined in a webcast that will take place today at 10:00 EST.

Axonyx anticipates initiating two Phenserine clinical trials in 2003. The first is a randomized placebo-controlled double-blind Phase II trial that will evaluate the effects of two different dosages of Phenserine given for a six month period on the levels of the beta-amyloid precursor protein (beta-APP) and beta amyloid in the plasma and cerebrospinal fluid of 75 mild to moderate Alzheimer's disease patients. This Phase II trial is intended to substantiate in vitro and in vivo preclinical data that has consistently shown that Phenserine can reduce the levels of beta-APP and beta amyloid. It is believed by many that one of the key underlying pathological processes in Alzheimer's disease is associated with the amyloid cascade and inhibition of this process could potentially modify Alzheimer's disease progression. Patients in this trial will also undergo testing with the standard memory and cognition tests recommended by the United States FDA and European regulatory authorities. This Phase II trial, to be undertaken at a facility in Europe, is anticipated to start before the end of March 2003.

The second trial that Axonyx is currently planning is designed to potentially be one of the pivotal Phase III trials for the NDA submission in the USA and its equivalent in Europe. This randomized double-blind placebo-controlled trial will be conducted at multiple centers throughout Europe. It will examine the safety and efficacy of two dosages of Phenserine given for a six-month period in mild to moderate Alzheimer's disease patients. The ability of Phenserine to improve memory and cognition will be measured by the standard ADAS-cog and CIBIC-plus efficacy endpoints, which are recommended by the FDA as well as the ADCS-ADL to meet European regulatory requirements. This Phase III trial will recruit up to 375 patients (including the 75 patients from the Phase II trial above). We anticipate, given sufficient financial resources, initiating this clinical trial in the second quarter of 2003.

"Finally being in the position to potentially confirm the unique dual action mechanism of Phenserine for the treatment of AD patients is both gratifying and exciting," said Gosse B. Bruinsma, M.D., C.O.O. of Axonyx, Inc. "We believe that undertaking this next phase of the Phenserine development program represents an important and significant step for both Axonyx and Phenserine."

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 planned clinical trials will be initiated on the timeline mentioned in the press release, that the planned clinical trials, or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the small Phase II trial will remain the same in these clinical trials, or future clinical trials, if any, that the preclinical results related to the regulation of beta-APP will translate into positive human data and that Phenserine will be able to slow the progression of Alzheimer's disease, that Axonyx will obtain the necessary financing to commence any Phase III Phenserine trials, that the FDA will grant marketing approval for Phenserine, that the FDA will approve the protocol for a Phase III trial, 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 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.