Merck halts clinical trial of Alzheimer's drug
Merck said it will halt a phase 2/3 clinical study of an experimental Alzheimer’s drug due to lack of efficacy.
The study evaluated verubecestat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with mild-to-moderate Alzheimer’s disease (AD).
Merck said the external data monitoring committee, which assessed overall benefit or risk of verubecestat, determined that there was virtually no chance of finding a positive clinical effect.
The phase 2/3 randomized, placebo-controlled, parallel-group, double-blind Epoch study assessed the efficacy and safety of two oral doses of verubecestat, including 12mg and 40 mg, administered once-daily against placebo in patients with mild-to-moderate AD currently using standard of care treatment.
Merck said that another late-stage study for the treatment of people with prodromal Alzheimer's disease would continue and results from the study are anticipated by February 2019.
Merck Research Laboratories president Dr Roger Perlmutter said: “Alzheimer’s disease is one of the most pressing and daunting medical issues of our time, with inherent, substantial challenges to developing an effective disease-modifying therapy for people with mild-to-moderate disease.”
Separately, Merck also announced that its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (MK-1439) met primary efficacy endpoint in pivotal phase III trial.
Doravirine is being developed for the treatment of HIV-1 Infection.
The study achieved its primary efficacy endpoint of the proportion of participants reaching levels of HIV-1RNA less than 50 copies/mL after 48 weeks of treatment.
It showed the non-inferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), in previously untreated (treatment-naïve) adults with HIV-1 infection.
The secondary endpoint demonstrated that the DOR-treated group had statistically significant lower levels of fasting low density lipoprotein cholesterol (LDL-C), against the DRV+r group.
Image: Merck to stop Epoch study that is evaluating verubecestat to treat people with mild-to-moderate Alzheimer’s disease. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.