Akero Therapeutics Announces Q1 2024 Financials and Business Update

Akero Therapeutics, a clinical-stage company, reported promising advancements in its development of treatments for serious metabolic diseases like pre-cirrhotic MASH. In the first quarter of 2024, they shared significant clinical progress and financial outcomes.

Andrew Cheng, President and CEO, emphasized the substantial progress made with EFX, Akero’s lead product candidate. The Phase 2b HARMONY study, aimed at patients with pre-cirrhotic MASH (F2-F3), showed notable improvements. By week 96, the fibrosis stage saw marked positive changes, especially with the 50mg dose of EFX showing a 75% improvement rate compared to 24% with placebo.

In March 2024, details from HARMONY highlighted significant enhancements at week 96 over week 24. Previously, primary endpoints of a one-stage fibrosis improvement without worsening MASH were met after 24 weeks, with 41% and 39% improvement rates for 50mg and 28mg EFX doses respectively, versus 20% for placebo. At week 96, these rates improved to 75% for 50mg EFX and 46% for 28mg EFX, while the placebo remained at 24%.

Additionally, the study revealed that 36% and 31% of patients on 50mg and 28mg EFX doses experienced a two-stage fibrosis improvement without MASH worsening, compared to just 3% with placebo. For patients with F3 fibrosis, 68% and 27% on 50mg and 28mg EFX doses showed a one-stage fibrosis improvement, significantly better than the 14% for placebo. These findings were bolstered by secondary endpoints showing improvements in liver enzymes, non-invasive fibrosis markers, glycemic control, and lipoproteins. EFX was well-tolerated overall, with a tolerability profile consistent with the earlier stages of the HARMONY study.

Meanwhile, Akero’s Phase 2b SYMMETRY study, focusing on patients with compensated cirrhosis due to MASH (F4), is projected to report 96-week results in the first quarter of 2025. This study continues to track well within its timeframe.

Akero’s Phase 3 SYNCHRONY program includes three trials. The SYNCHRONY Histology and SYNCHRONY Real-World trials began enrolling patients in December 2023, while the SYNCHRONY Outcomes trial is set to start in the second quarter of 2024. The SYNCHRONY Histology trial aims to include approximately 1,000 patients with pre-cirrhotic MASH, assessing fibrosis improvement and MASH resolution over 52 weeks. The SYNCHRONY Real-World trial seeks to enroll around 700 patients diagnosed with MASH or MASLD and will evaluate safety and tolerability. The SYNCHRONY Outcomes trial will focus on patients with compensated cirrhosis due to MASH.

In March 2024, Akero completed a public offering of 12,650,000 shares at $29.00 each, raising approximately $366.9 million. As of March 31, 2024, Akero had $903.7 million in cash and investments, sufficient to fund its SYNCHRONY studies through primary endpoints and its operational plan into the second half of 2027.

Financially, Akero reported increased research and development expenses in the first quarter of 2024, reaching $50.7 million, up from $21.8 million in the same period of 2023. This rise was due to the progression of the HARMONY study, the ongoing SYMMETRY study, and the initiation of Phase 3 SYNCHRONY studies. General administrative expenses also rose to $9.3 million from $7.0 million, driven by higher personnel and operational costs.

Efruxifermin (EFX) shows promise against MASH by reducing liver fat, inflammation, and fibrosis, while improving insulin sensitivity and lipids, targeting the complex disease profile of MASH. MASH, a severe form of MASLD, affects millions and is a leading cause of liver transplants and cancer in the US and Europe.

Akero Therapeutics, headquartered in South San Francisco, continues to advance its clinical trials to bring transformative treatments for metabolic diseases to patients in need.