Akero Therapeutics (AKRO) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Clinical development and trial updates

• Three phase III trials are ongoing for NASH/MASH in both pre-cirrhotic and cirrhotic patients, with first phase III readouts expected in 2026 and histology data in early 2027.

• A phase IIb readout in the cirrhotic study is anticipated in February 2025.

• The phase III study uses a commercial dual-chamber injector formulation, stable at room temperature and designed for patient convenience.

• The phase III trial enrolled its first patient in September and aims for over 1,000 participants, with a primary histology endpoint at two years.

• Discontinuation rates are influenced by administrative and personal factors, but a meaningful number of patients are expected to complete the 96-week study.

Market landscape and competitive positioning

• Recent approval and strong launch of Rezdiffra, along with positive phase III data for semaglutide, indicate robust patient demand and market potential for NASH/MASH therapies.

• Entry of major players like Novo is expected to further validate and expand the market.

• FGF21s, including efruxifermin, are positioned as direct-acting anti-fibrotics with rapid and significant fibrosis reduction, differentiating them from current therapies.

• Efruxifermin demonstrated a 75% regression rate and over 50% effect size at two years in pre-cirrhotic patients, a high benchmark compared to competitors.

Differentiation and product profile

• Efruxifermin and Boston Pharma’s FGF21 are both Fc fusion proteins, while 89bio’s is pegylated; all show similar short-term efficacy, but long-term data may distinguish efruxifermin.

• The commercial formulation is patient-friendly, requires no cold chain, and offers flexible dosing.

• Bone health is being closely monitored, with about 3% bone loss at two years, considered manageable and being addressed in phase III.