Akero Therapeutics

Expedition Therapeutics closed an oversubscribed $165 million Series A financing co-led by Sofinnova Investments and Novo Holdings to advance EXPD-101, a next-generation DPP1 inhibitor targeting neutrophilic inflammation in COPD.

Novo Nordisk announced the acquisition of Akero Therapeutics for up to $5.2 billion, gaining access to efruxifermin (EFX), a promising treatment for metabolic dysfunction-associated steatohepatitis (MASH).

Roche announced a definitive merger agreement to acquire 89bio for $14.50 per share in cash plus contingent value rights, totaling up to $3.5 billion.

TREM2-expressing macrophages play crucial roles in metabolic dysfunction-associated steatohepatitis (MASH) by regulating both lipid metabolism and immune homeostasis through specialized signaling pathways.

DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ liver cirrhosis therapies, with promising candidates like Rezdiffra, efruxifermin, and belapectin showing significant clinical progress.

Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial.

• Areteia Therapeutics is progressing dexpramipexole, a novel oral therapy, into Phase III clinical trials for severe eosinophilic asthma. • Dexpramipexole aims to reduce eosinophil levels by inhibiting their maturation in the bone marrow, offering a potential alternative to injectable biologics. • Akero Therapeutics will present updates on its MASH treatment, EFX, currently in Phase 3 trials, at the J.P. Morgan Healthcare Conference. • Both Areteia and Akero will present at the J.P. Morgan Healthcare Conference on January 14, 2025, to discuss their clinical-stage programs.

• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. • This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes. • Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape. • The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.

• Boston Pharmaceuticals' efimosfermin alfa demonstrated statistically significant fibrosis improvement in MASH patients, with 45.2% showing at least a one-stage improvement compared to 20.6% in the placebo group. • The Phase II trial also revealed that 67.7% of patients treated with efimosfermin alfa achieved MASH resolution without fibrosis worsening, versus 29.4% in the placebo group, indicating a significant treatment effect. • Efimosfermin alfa, a long-acting FGF21 analog administered monthly, offers a potentially more convenient dosing schedule compared to other FGF21 analogs in development for MASH. • The drug exhibited a good tolerability profile over 24 weeks, with a low incidence of injection-site reactions and gastrointestinal toxicities, supporting its further development.

• Akero Therapeutics' efruxifermin (EFX) demonstrates significant anti-fibrotic effects in patients with F2/F3 MASH, as shown in the Phase 2b HARMONY study. • The Phase 3 SYNCHRONY study, assessing EFX's safety and tolerability, has completed enrollment, with top-line data expected in the first half of 2026. • Analysts maintain a Buy rating for Akero, citing the potential of EFX in treating MASH and MASLD, along with market exclusivity projected through 2037. • Upcoming results from the Phase 2b SYMMETRY study, focusing on EFX’s effects in F4 MASH, are anticipated as a critical catalyst for the company’s future.