Akero Therapeutics
Akero Therapeutics, founded in 2017 and headquartered in South San Francisco, pioneers novel therapies for serious metabolic diseases, focusing on Efruxifermin (EFX) for metabolic dysfunction-associated steatohepatitis (MASH). EFX, an Fc-FGF21 fusion protein, has shown potential in reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipids.
Introduction to Akero Therapeutics
Akero Therapeutics is a biopharmaceutical company dedicated to pioneering novel therapies aimed at transforming the lives of individuals living with severe metabolic diseases. The company focuses on advancing its lead product candidate, Efruxifermin (EFX), specifically targeting metabolic dysfunction-associated steatohepatitis (MASH). Akero Therapeutics is headquartered in South San Francisco, California, and was established in 2017.
Efruxifermin (EFX) for MASH
Efruxifermin (EFX) is Akero Therapeutics' lead product candidate designed to treat metabolic dysfunction-associated steatohepatitis (MASH). EFX is a differentiated Fc-FGF21 fusion protein, mimicking the balanced biological activity of native FGF21. It targets the core drivers of MASH progression, including reducing liver fat and inflammation, reversing fibrosis, increasing insulin sensitivity, and improving lipid profiles. EFX is intended for once-weekly dosing and has generally been well tolerated in clinical trials. The drug has been granted Breakthrough Therapy Designation by the US FDA for treating MASH.
Clinical Trials Evaluating EFX
Akero Therapeutics has numerous ongoing clinical trials to assess the efficacy of Efruxifermin (EFX) for MASH. The Phase 3 SYNCHRONY program includes three trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. SYNCHRONY Histology aims to enroll about 1,000 patients, while SYNCHRONY Real-World will enroll approximately 600 patients. The SYNCHRONY Outcomes trial will evaluate EFX in patients with compensated cirrhosis due to MASH. Additionally, the Phase 2b HARMONY study showed significant histological improvements at week 96, and the Phase 2b SYMMETRY study is investigating EFX's benefits when combined with GLP-1 therapy.
Financial Overview
In March 2024, Akero Therapeutics raised approximately $366.9 million through a public offering. As of March 31, 2024, the company reported having $903.7 million in cash, cash equivalents, and short-term marketable securities. For the first quarter of 2024, Akero's research and development expenses were $50.7 million, and general and administrative expenses amounted to $9.3 million. Total operating expenses for the quarter were $60.0 million.
Partnerships and Corporate Developments
Akero Therapeutics has partnered with notable companies such as Boehringer-Ingelheim and Vetter Pharma for the manufacturing of Efruxifermin (EFX). Additionally, Akero completed the renovation of its new corporate headquarters in South San Francisco, California. The company also achieved a significant milestone by closing an upsized IPO. Akero holds an exclusive, global license from Amgen to develop EFX further.