Another Nail In Amyloid Hypothesis Coffin? Merck Ends Pivotal BACE Inhibitor Study

 
• By Mandy Jackson
  
Generate a summary of this article
Listen to this article
Beta

In another blow for the amyloid hypothesis in Alzheimer's disease, Merck ended its pivotal EPOCH study for the BACE inhibitor verubecestat based on an interim assessment that there was "virtually no chance of finding a positive clinical effect" in the nearly completed Phase II/III clinical trial.

Human brain illustrated with millions of small nerves - Conceptual 3d render

Merck & Co. Inc. revealed on Feb. 14 that it has ended the Phase II/III EPOCH clinical trial testing the BACE inhibitor verubecestat in mild-to-moderate Alzheimer's disease based on lack of efficacy, seeming to put another nail in the coffin for the amyloid hypothesis, although the company's Phase III trial in prodromal Alzheimer's is ongoing with results expected in Feb. 2019.

An external data monitoring committee determined after an interim safety analysis that verubecestat (MK-8931) had "virtually no chance of finding...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By Xu Hu

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By Xu Hu

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D