Axonyx公司治疗 Alzheimer病的药物在Ii期试验
NEW YORK (Reuters Health) - Axonyx Inc. on Tuesday reported positive phase II results for its lead drug candidate Phenserine (N-phenylcarbamoyl eseroline) in treating Alzheimer's disease.
Phenserine, an acetylcholinesterase inhibitor, was tested in a double-blind, placebo-controlled trial of 72 patients with mild-to-moderate Alzheimer's disease.
Axonyx said that the trial results suggest the drug may have a better side-effect profile than currently-marketed acetylcholinesterase inhibitors. The company stressed that the incidence of nausea and vomiting, which it called the most debilitating adverse event associated with the drug class, was only about 8.5% in the study.
Marketed acetylcholinesterase inhibitors include Novartis' Exelon (rivastigmine tartrate) and Pfizer's Aricept (donepezil).
The Phenserine study was not designed to measure efficacy. However, results indicated that the drug appeared to improve memory and cognition over the 12-week treatment period, according to Axonyx.
In a conference call on Monday, Axonyx CEO Dr. Marvin Hausman said that the company would meet with the US Food and Drug Administration over the next few months to review phase III protocols. One issue that is likely to arise is whether the agency will allow a change in subjects' scores on the CANTAB cognition test--which was used in the phase II study--to serve as a primary endpoint, company officials noted.
The phase III trial could involve higher dosages than those evaluated in phase II in an attempt to maximize efficacy, they added.
Hausman said that Axonyx is considering a number of options to fund the continuing development of Phenserine, including entering a development partnership, out-licensing the drug and raising additional capital. The firm licensed exclusive worldwide rights to Phenserine from the National Institutes of Health., 百拇医药
Phenserine, an acetylcholinesterase inhibitor, was tested in a double-blind, placebo-controlled trial of 72 patients with mild-to-moderate Alzheimer's disease.
Axonyx said that the trial results suggest the drug may have a better side-effect profile than currently-marketed acetylcholinesterase inhibitors. The company stressed that the incidence of nausea and vomiting, which it called the most debilitating adverse event associated with the drug class, was only about 8.5% in the study.
Marketed acetylcholinesterase inhibitors include Novartis' Exelon (rivastigmine tartrate) and Pfizer's Aricept (donepezil).
The Phenserine study was not designed to measure efficacy. However, results indicated that the drug appeared to improve memory and cognition over the 12-week treatment period, according to Axonyx.
In a conference call on Monday, Axonyx CEO Dr. Marvin Hausman said that the company would meet with the US Food and Drug Administration over the next few months to review phase III protocols. One issue that is likely to arise is whether the agency will allow a change in subjects' scores on the CANTAB cognition test--which was used in the phase II study--to serve as a primary endpoint, company officials noted.
The phase III trial could involve higher dosages than those evaluated in phase II in an attempt to maximize efficacy, they added.
Hausman said that Axonyx is considering a number of options to fund the continuing development of Phenserine, including entering a development partnership, out-licensing the drug and raising additional capital. The firm licensed exclusive worldwide rights to Phenserine from the National Institutes of Health., 百拇医药