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.
