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Second Phase 3 Trial of Phenserine in Alzheimer's Disease Launched
This second Phase III trial will recruit patients to randomly receive Phenserine 10mg twice daily, Phenserine 15mg twice daily or placebo. Axonyx initiated the first randomized, placebo-controlled double-blind Phase III trial in June of 2003 and data from this trial are anticipated to be ready for analysis by the end of 2004. Patients in both trials undergo testing with the standard memory and cognition tests that are the efficacy endpoints required by the US FDA and European regulatory authorities for potential marketing approval. As with all of the ongoing clinical trials that Axonyx conducts, all patients completing each 6-month clinical trial treatment period are offered the opportunity to continue to receive Phenserine for an additional 6-month period in an associated extension trial. These extension trials provide the company with long-term safety and efficacy data.
Based on the data packages of the marketed products in the same drug class as Phenserine, Axonyx anticipates initiating one additional international Phase III safety and efficacy clinical trial in the near future. This trial will ensure that sufficient data is provided to the US FDA and European Regulatory Agencies to meet their patient drug exposure and safety requirements. Regulatory Agencies, including the US FDA, generally require that two Phase III trials have positive safety and efficacy outcomes in order for an NDA or its equivalent to be potentially approvable.
Phenserine is an acetylcholinesterase and beta amyloid precursor protein (ß-APP) inhibitor that is being developed by Axonyx for the treatment of mild to moderate AD patients. Phenserine is currently also 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 initiation of this second Phase III trial signifies our ongoing confidence and commitment to bring Phenserine to approvable NDA status," stated Gosse B. Bruinsma, M.D., President & Chief Operating Officer of Axonyx Inc., "Our clinical development program is on course and we are optimistic that the final data package will support the potential approval of Phenserine."