A new drug against Alzheimer's disease has entered the second phase of CI
Merck has initiated a phase II/III clinical trial of a drug intended for the treatment of Alzheimer's disease. MK-8931 is a new experimental drug for oral use, the mechanism of action of which is to inhibit the beta–secretase enzyme (BACE) involved in the synthesis of beta-amyloid.
According to the amyloid hypothesis, it is generally believed that the root cause of the development of Alzheimer's disease is the formation of beta-amyloid molecules accumulating in the brain tissue of patients in the form of amyloid deposits or plaques. Accordingly, the drug MK-8931, which blocks the formation of amyloid peptides, should prevent the development of Alzheimer's disease.
During the phase I clinical trial, Merck specialists demonstrated that MK-8931 reduces the beta-amyloid content in the cerebrospinal fluid by more than 90%, while not having any side effects that determine the upper dose limit.
The new Phase II/III study (EPOCH) is planned as a 78-week, double-blind, randomized, placebo-controlled clinical trial involving 200 patients with Alzheimer's disease. During the study, experts will evaluate the safety of MK-8931 and compare the effectiveness of three daily dosages of the drug (12, 40 and 60 mg) with the effectiveness of placebo.
According to Dr. Darryl Shoepp, First Vice President and Head of the Neurology and Ophthalmology Department of Merck's research division. Schoepp), the growing financial burden caused by Alzheimer's disease on a global scale, causes an urgent need for innovative research in this direction. The new clinical trial conducted by Merck is an important step forward in the work on the strategy of studying the potential of the mechanism of inhibition of beta-secretase, as well as MK-8931 – the most promising experimental drug of the company – at different stages of Alzheimer's disease.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on materials from Merck & Co., Inc.:
Merck Initiates Phase II/III Study of Investigational BACE Inhibitor, MK-8931, for Treatment of Alzheimer's Disease.
05.12.2012