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Akero Therapeutics (AKRO) investor relations material
Akero Therapeutics Morgan Stanley 23rd Annual Global Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key clinical insights and data
Three phase III programs are underway, targeting MASH with a focus on both cirrhotic (F4) and pre-cirrhotic (F2/F3) populations.
Efruxifermin, an FGF21 analog, demonstrated a 24% effect size in F4 patients and a 52% effect size in F2/F3 patients for one-stage fibrosis improvement in recent studies.
Safety profile is consistent, with diarrhea and nausea most common; bone mineral density loss (~5%) is being managed proactively in phase III.
Phase III SYNCHRONY program includes real-world, histology, and outcomes studies, with global enrollment and a more patient-friendly drug formulation.
Amendments to trial protocols are being considered to optimize patient selection based on phase IIb data.
Regulatory and competitive landscape
Two drugs (Rezdiffra and semaglutide) are now approved for MASH in the U.S., but only for F2/F3; no approved therapies exist for F4.
Efruxifermin shows a higher effect size than approved agents (Rezdiffra ~11.5%, semaglutide ~14.5%) and is positioned for both F2/F3 and F4 populations.
Accelerated approval is possible in Europe for F4 based on histology, but U.S. FDA guidance is less clear; regulatory timelines depend on ongoing enrollment and data.
Other FGF21 programs are in development, but many have been discontinued; robust clinical data is seen as a key differentiator.
Market opportunity is significant and growing, with only two products currently available and high unmet need, especially in F4.
Innovation and future outlook
AI is being used for pathology analysis in clinical trials, showing high correlation with human pathologists, though not yet accepted by the FDA.
The SYNCHRONY Real-World study will provide the largest safety dataset to date, with results expected in the first half of next year.
Global phase III studies are ongoing, with no expected geographic differences in response.
The company is monitoring innovation from China and sees the need for definitive clinical data before considering competition from emerging FGF21s.
The market is expected to expand as more companies enter and as unmet needs in advanced fibrosis are addressed.
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