US pharmaceutical company Merck has announced that it is ending a late-stage Alzheimer’s drug study on the recommendation of an external committee.
The APECS study was conducted to evaluate the safety and efficacy of verubecestat (MK-8931), a beta-site amyloid precursor protein cleaving enzyme 1 (BACE1) inhibitor, for the treatment of amnestic mild cognitive impairment due to Alzheimer’s disease.
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BACE1 inhibitors are drugs that block the protein amyloid beta that is believed to be the major cause of Alzheimer’s disease. With an effective treatment using BACE1 inhibitors yet to be developed, a successful product would have a major impact on the Alzheimer’s drug market.
In the trial, participants were randomised to receive a placebo or 12 mg or 40 mg of verubecestat once-daily for 104 weeks. Data from the study will be presented at an upcoming medical meeting.
The decision follows a recommendation by an external data monitoring committee that concluded that it was unlikely that positive benefit/risk could be established if the trial continued. This comes 12 months after Merck ended a phase III trial of the same candidate for the treatment of established mild-to-moderate Alzheimer symptoms.
Shares of Merck declined almost 1% following this latest announcement.
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By GlobalData“We are disappointed with this outcome, especially given the lack of treatment options for patients suffering from Alzheimer’s disease,” said president of Merck Research Laboratories Dr Roger Perlmutter.
“We are grateful to the patients and caregivers who participated in this study, and despite this outcome, Merck remains committed to developing novel therapies for the treatment of Alzheimer’s and other neurodegenerative diseases.”
The announcement adds to an extensive list of setbacks in Alzheimer’s research, with no new drugs to treat the disease approved in the last 15 years. Several candidates have been discontinued, including Roche’s RG7129, Eli Lilly’s LY2886721 and Vitae/Boehringer Ingelheim‘s BI 1181181. In January 2018, Pfizer announced that it would be ending its research into new Alzheimer’s and Parkinson’s drugs.
Although several pharmaceutical companies are currently conducting trials of BACE1 inhibitors─with AstraZeneca and Eli Lilly currently co-developing a drug─late-stage trial failures cast doubts over their efficacy. Although BACE1 inhibitors have been shown to reverse early-stage Alzheimer’s in mice, high-profile clinical trials are failing to produce results supporting their efficacy in treating the disease in humans.
