Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Merck Alzheimer’s Drug Fails in One Study; Another Continues

By Mike Botta | February 15, 2017

Merck & Co. will stop its study of an experimental Alzheimer’s drug in people with mild or moderate symptoms because interim results showed “virtually no chance” of any benefit.

However, the drugmaker said Tuesday it will continue another study of the drug, verubecestat, in patients who don’t yet show symptoms. They have some memory problems, but can still perform daily activities.

The two studies were intended to enable Merck to seek regulators’ approval to sell verubecestat.

Merck, known as MSD outside the United States and Canada, announced that it will be stopping protocol 017, also known as the EPOCH study, a Phase 2/3 study evaluating 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 is stopping the study following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during a recent interim safety analysis, and determined that there was “virtually no chance of finding a positive clinical effect.”

The eDMC noted that safety signals observed in the study “are not sufficient to warrant stopping study 017,” and recommended that protocol 019, also known as APECS, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged. Results from protocol 019 are expected in February 2019. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting.

“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,” Dr. Roger M. Perlmutter, president, Merck Research Laboratories, said. “Studies such as EPOCH are critical, and we are indebted to the patients in this study and their caregivers. While we are disappointed that a benefit was not observed in this study, our work continues with APECS, which is studying verubecestat in people with less advanced disease.”

The efficacy and safety of verubecestat was being evaluated in two pivotal Phase 3 clinical trials: Protocol 017, or EPOCH, in mild-to-moderate AD, and Protocol 019, or APECS, in prodromal AD. Patients with mild to moderate AD exhibit detectable and worsening impairment of cognitive and functional abilities. Patients with prodromal AD have objective memory problems but relatively normal functioning in activities of daily living.

Alzheimer’s is one of the toughest diseases to treat.

While a few treatments temporarily ease symptoms such as memory loss, confusion and agitation, dozens of drugs tested have failed to slow mental decline or halt the mind-robbing disease, including the one Eli Lilly & Co. scrapped in November.

(Sources: Associated Press; Business Wire)


Filed Under: Drug Discovery

 

Related Articles Read More >

Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
Prime time for peptide-based drug discovery 
Why smaller, simpler molecular glues are gaining attention in drug discovery
Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation
Unlocking ‘bench-to-bedside’ discoveries requires better data sharing and collaboration
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE