89bio’s Phase IIb Data Heighten Competition Within NASH FGF21 Analog Class

89bio’s pegozafermin met co-primary endpoints of fibrosis reduction and NASH resolution in Phase IIb; the company said its methodology yielded lower placebo responses than in Akero’s Phase IIb study.

Two racers
Competition between 89bio and Akero in NASH is tightening • Source: Shutterstock

The street hailed 89bio, Inc.’s Phase IIb top-line data readout for pegozafermin (BIO89-100) in non-alcoholic steatohepatitis (NASH) on 22 March, saying it largely levels the playing field with Akero Therapeutics, Inc. and its FGF21 analog, which yielded successful Phase IIb data last September. One analyst called the 89bio dataset “unequivocally robust and definitive PoC results,” while another asserted that the two companies’ recent data position the FGF21 class as the best “high-efficacy mechanism” in NASH.

[Sidebar#SC147071]

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.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    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 

    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