Akero Therapeutics (AKRO) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Lead program overview

• Efruxifermin is an FGF21 analog agonist with dual mechanisms: direct antifibrotic action and reduction of liver fat from both hepatic and extrahepatic sources.

• Differentiates from other FGF21s by being a bivalent fusion protein with a 3–4 day half-life.

• Targets a large market, with 20–22 million Americans affected by NASH and only one approved therapy as of March.

Market landscape and treatment positioning

• NASH is the leading cause of liver transplantation in the US, with significant unmet need.

• GLP-1s are widely used in NASH patients due to overlap with diabetes and obesity, but lack a NASH indication and show limited efficacy in advanced fibrosis (F4).

• Efruxifermin shows potential for use in F2/F3 patients, non-responders, and in combination with GLP-1s.

Clinical data highlights

• HARMONY study (F2/F3): At 96 weeks, 75% of patients on 50 mg efruxifermin had a one-stage fibrosis improvement, with a 51% effect size over placebo.

• 36% achieved two-stage fibrosis improvement at two years, a rare outcome in NASH trials.

• Longer dosing increases both breadth and depth of response.

• Combination with GLP-1s led to 90% normalization of liver fat and improved glycemic and lipid parameters without additive GI side effects.