Gilead’s FXR Agonist Posts Questionable Results In NASH, But Offers Hope In PSC

 
• By Joseph Haas
  
Generate a summary of this article
Listen to this article
Beta

Although GS-9674’s efficacy data don’t appear as promising as that for Intercept’s competing FXR agonist OCA, Gilead seems to be building an argument that its drug has a better combination of efficacy and safety.

scientists doing lab research on digital screen

Gilead Sciences Inc. unveiled Phase II data for its farnesoid X receptor (FXR) agonist GS-9674 in non-alcoholic steatohepatitis (NASH) that raise doubts for its promise in that indication compared to other candidates from the same class, but Gilead’s drug fared better in a primary sclerosing cholangitis (PSC) trial, showing improvements in liver biochemistry and markers of cholestasis.

A competing NASH candidate, Intercept Pharmaceuticals Inc.'s obeticholic acid (OCA), showed the ability to reduce both fibrosis and steatosis...

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