Merck, known as MSD outside the US and Canada, has commenced a Phase II/III study of MK-8931 for the treatment of Alzheimer’s disease.
The Phase II/III trial will assess the safety and efficacy profile of MK-8931, an investigational oral ß-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, against a placebo.
Merck Research Laboratories neuroscience and ophthalmology senior vice president and head Dr Darryle Schoepp said; "This new study is an important step in our overall strategy to understand the potential of the BACE inhibitor mechanism and MK-8931, our lead compound, in multiple stages of Alzheimer’s disease."
EPOCH multi-centre, randomised study will initially assess the MK-8931 safety profile in a 200 patient cohort prior to advancing into a larger Phase III study.
The 78-week, placebo-controlled, Phase II/III trial will assess one of three oral doses in strengths 12mg, 40mg and 60 mg of MK-8931 for efficacy and safety against placebo when administered daily.
The parallel-group, double-blind study is expected to enrol around 1,700 patients in the main Phase III cohort.
The change from baseline in the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer’s Disease Cooperative Study, Activities of Daily Living (ADCS-ADL) score will be the primary efficacy outcomes.
MK-8931 demonstrated reduction in cerebral spinal fluid ß-amyloid by more than 90% in healthy volunteers, without dose limiting side effects in a multiple dose Phase I study.