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Expert Interview

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Comparing 89bio's ENLIVEN data (pegozafermin) to Akero's efruxifermin in NASH


Who's the expert?

Institution: Imperial College London

  • Consultant Hepatologist at Imperial College Healthcare NHS Trust, and Honorary Senior Lecturer at Imperial College London.
  • Leads the NAFLD service in the Trust, overseeing a clinic that cares for more than 600 patients.
  • Research interests are focused in translational aspects of NAFLD care, including prediction of cardiovascular risk, quantitation of liver biopsies from NAFLD patients using machine learning, and management of NAFLD cirrhosis. 

Interview Questions

What are your thoughts on pegozafermin's ph.II ENLIVEN data ?

Added By: kenny

Fibrosis improvement in placebo (7%) was the lowest compared to historical ph.II trials (15%+). Co used a 3-panel cons. read with stringent scoring criteria (similar to ICPT's REGENERATE). 

  • Do you believe this PBO is realistic and reflective of real-world histology read? 

Added By: kenny

Both AKRO and ETNB had 20% fibrosis improvement, but AKRO's PBO and efruxifermin results were numerically higher (20% PBO vs 41% EFX, and 7% vs 27% PEGZO).

  • How do u make sense of these differences? Should 20% delta be viewed similar? Or do you view efruxfermin's numerically higher 41% as more favorable , despite both at 20% delta?  

Added By: kenny

What are your thoughts on NASH improvement and why do you think pegzogafermin's effect size was lower compared to efruxifermin? (24% delta in 44mg PEGZO vs. 61% EFX 50mg).

co cites ballooning histology read variability caused lower results

Added By: kenny

What are your thoughts on the non-invasive biomarkers shown (Fibroscan, liver enzymes, pro-C3) and the correlation to NASH & fibrosis results? Does any marker stand out?

Added By: kenny

When you look at the more objective efficacy efficacy measures (liver enzymes, weight loss, VCTE on Fibroscan), we see greater effect size in EFX compared to PEG. But when looking at partially subjective measures like fibrosis, they both show a comparable 20% delta.
  • How do you make sense of the differences between objective and subjective measures? Dose it imply pegzogafermin's fibrosis response is driven by favorable pathology readers, vs. actual drug effect?
  • Do you believe pegzogafermin ph.II results are reproducible in ph.III? 
  • Do you believe efruxfermin is a more potent FGF21 given deeper effect size in NASH and objective markers , despite similar fibrosis improvement? 

    Added By: kenny

    Thinking about the FGF21 MOA and how it works biologically, shouldn't NASH resolution be much higher than fibrosis improvement? For example, EFX had a much higher 3x NASH resolution of 61% delta vs 20% delta in fibrosis. This higher NASH improvement vs fibrosis improvement is also seen in previous NASH trials.

    • However, pegzogafermin's NASH vs fibrosis improvement was very similar, almost 1:1 (24% NASH vs 20% fibrosis delta). How do you make sense of this?
    • Does lower NASH efficacy vs efruxfermin imply FGF21a,1b,1c receptor differences? Both compounds have nM potency.  

    Added By: kenny

    Weight loss 

    • pegozafermin did not show weightloss vs. efruxifermin. Do you believe this is due to drug differences, or patient selection? What are the clinical implications? (eg. better F4 outcomes in lean muscle mass preservation)

    Added By: kenny

    How would you sum up Pegzogafermin vs efruxfermin's product profile?

    • Would pegzogafermin's better safety (lower GI tox, no tremors), comparable fibrosis efficacy, and more flexible Q2W dose a good assessment?
    • Assuming efrixfermin, resmetirom and pegzogafermin all get approved, how do you see them being used?


    Added By: kenny

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