Akero Looks To Accelerate Path To Pivotal NASH Data With Phase IIb/III Protocol

89Bio Builds Case For Safety Advantage As FGF Competition Heats Up

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

Akero gets FDA’s ok to conduct Phase IIb/III study of FGF21 analog efruxifermin in biopsy-confirmed non-alcoholic steatohepatitis patients. With NASH leadership up in the air, Akero, 89bio and other FGF analog sponsors jockey for top spot.

adaptive design - text in vintage letterpress wood type against grunge metal surface
Akero's Phase IIb/III adaptive trial is a first in NASH

Competition is heating up in the FGF21 analog class for non-alcoholic steatohepatitis, with Akero Therapeutics, Inc. preparing to initiate an adaptive Phase IIb/III study of its drug efruxifermin (EFX/AKR-001), which it says could provide a relatively quick path to producing pivotal data and give it a boost as the NASH space resettles after this year’s clinical development setbacks for Intercept Pharmaceuticals, Inc. and Genfit SA.

Leadership in the NASH space generally is seen as wide open again after Genfit’s Phase III failure in May with...

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