Akero Therapeutics

Akero Therapeutics, established in 2017 and headquartered in South San Francisco, California, is dedicated to pioneering novel therapies aimed at transforming the lives of individuals living with serious metabolic diseases. The company’s primary focus is on advancing Efruxifermin (EFX), a differentiated Fc-FGF21 fusion protein, as a treatment for metabolic dysfunction-associated steatohepatitis (MASH). EFX is designed to mimic the balanced biological activity of native FGF21 and aims to address all core drivers of MASH progression, including reducing liver fat and inflammation, reversing fibrosis, increasing insulin sensitivity, and improving lipid profiles. EFX is administered through once-weekly dosing and has been generally well tolerated in clinical trials to date. MASH, a serious form of metabolic dysfunction-associated steatotic liver disease (MASLD), is characterized by excessive fat accumulation in the liver, leading to inflammation and fibrosis, and can progress to cirrhosis, liver failure, cancer, and death. MASH is the fastest-growing cause of liver transplants and liver cancer in the US and Europe. Akero’s Phase 3 SYNCHRONY program includes three trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, with the first expected to enroll approximately 1,000 patients and the second approximately 600 patients. The SYNCHRONY Outcomes trial will evaluate EFX in patients with compensated cirrhosis due to MASH. The Phase 2b HARMONY study showed statistically significant histological improvements at week 96, while the ongoing Phase 2b SYMMETRY study is evaluating EFX in patients with compensated cirrhosis due to MASH. Akero raised approximately $366.9 million in a public offering in March 2024, and as of March 31, 2024, held $903.7 million in cash, cash equivalents, and short-term marketable securities. Research and development expenses for Q1 2024 were $50.7 million, with general and administrative expenses at $9.3 million, totaling $60.0 million in operating expenses. EFX has been granted Breakthrough Therapy Designation by the US FDA for the treatment of MASH. Akero has partnered with Boehringer-Ingelheim and Vetter Pharma for manufacturing and completed the renovation of its new corporate headquarters in South San Francisco. The company closed an upsized IPO at the top of the range just a year after obtaining its first biotech asset and entered an exclusive, global license from Amgen to develop EFX. The Phase 2b HARMONY study met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment, and the Phase 2b SYMMETRY study showed that adding EFX to GLP-1 therapy significantly improved non-invasive markers of MASH. The Phase 2a BALANCED study demonstrated positive and consistent improvements across multiple parameters for MASH.