Akero Therapeutics (AKRO) BofA Securities 2025 Healthcare Conference summary

Mechanism and differentiation of EFX

• Efruxifermin (EFX) acts both by rapidly removing liver fat and directly inhibiting collagen synthesis in hepatic stellate cells, offering unique anti-fibrotic effects compared to other agents.

• EFX's C-terminal modifications enhance binding to the β-klotho co-receptor, improving its efficacy and extending its half-life to three to four days.

• EFX demonstrates faster and more robust fibrosis responses than other mechanisms, with significant improvements seen within 24 weeks.

Clinical data and impact

• SYMMETRY phase IIb data showed 39% of patients on EFX had ≥1 stage fibrosis improvement at 96 weeks, compared to 15% on placebo, with no MASH worsening.

• This is the first agent to show statistically significant fibrosis improvement in cirrhotic (F4) MASH patients, challenging the belief that cirrhosis is irreversible.

• Improvement from F4 to F3 could translate to a substantial increase in life expectancy for patients.

• Longer dosing with EFX increases efficacy, with no plateau reached at 96 weeks.

Regulatory and market landscape

• The March 2024 approval of a competitor's drug reset expectations for the field, showing FDA willingness to approve and price such therapies well.

• Regulatory clarity exists for pre-cirrhotic populations, with SYMMETRY Histology results expected to support filing in the first half of 2027.

• Accelerated approval for cirrhotic patients remains uncertain, but ongoing discussions with regulators are planned.