Akero Therapeutics Q3 2024 Financial Results and Business Update

Akero Therapeutics, Inc., a clinical-stage biotechnology company, has reported significant progress and financial results for the third quarter ending September 30, 2024. The company, which focuses on developing treatments for serious metabolic diseases, shared updates on its lead candidate, efruxifermin (EFX), which is being evaluated in several Phase 3 clinical trials for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

The third quarter of 2024 was pivotal for Akero with the initiation of patient dosing in the Phase 3 SYNCHRONY Outcomes study. Akero's president and CEO, Andrew Cheng, highlighted that with this advancement, all three of their Phase 3 studies are currently enrolling participants, moving closer to potentially delivering a new treatment option for MASH patients.

The Phase 3 SYNCHRONY program consists of three ongoing randomized, placebo-controlled trials designed to evaluate the safety and tolerability of EFX. These trials support marketing applications for both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH. This program builds on previous Phase 2b studies that involved up to 300 patients treated for nearly two years.

The SYNCHRONY Outcomes study focuses on patients with compensated cirrhosis (F4) due to MASH. Participants in this study receive weekly injections of either EFX 50mg or a placebo. The primary endpoint for Cohort 1 is the proportion of patients experiencing at least a one-stage improvement in fibrosis with no worsening of steatohepatitis after 96 weeks of treatment. The overall primary outcomes endpoint for all enrolled patients measures the time to the first occurrence of any protocol-specified clinical events.

The SYNCHRONY Histology study involves patients with pre-cirrhotic MASH at fibrosis stages 2 or 3 (F2-F3). These patients receive weekly injections of EFX 28mg, EFX 50mg, or a placebo. The primary histology endpoint for Cohort 1 aims to support an accelerated approval application and is defined by the proportion of patients achieving at least a one-stage fibrosis improvement and resolution of MASH after one year of treatment. Long-term clinical outcomes will be monitored for up to 240 weeks, with primary results expected in the first half of 2027.

The SYNCHRONY Real-World study includes patients with MASH or metabolic dysfunction-associated steatotic liver disease (MASLD), receiving weekly injections of EFX 50mg or a placebo. The primary endpoint of this study is to assess safety and tolerability after 52 weeks of treatment, with results anticipated in 2026.

Additionally, the Phase 2b SYMMETRY study is evaluating the efficacy and safety of EFX in patients with compensated cirrhosis (F4) due to MASH. These patients were treated with EFX 28mg, EFX 50mg, or a placebo for up to 96 weeks. All planned end-of-treatment biopsies have been collected, and follow-up assessments are ongoing. Results from this study are expected in February 2025.

Financially, Akero reported cash, cash equivalents, and short and long-term marketable securities totaling $787.1 million as of September 30, 2024. The company believes this will be sufficient to fund its current operating plan into the second half of 2027, including the completion of the Phase 3 SYNCHRONY Histology and Real-World studies.

Research and development expenses for the third quarter were $72.2 million, a significant increase from $38.6 million in the same period in 2023. This rise is attributed to the ongoing SYNCHRONY Histology and Real-World studies, the initiation of the SYNCHRONY Outcomes study, and the production of clinical supplies for Phase 3 trials and potential marketing applications. General and administrative expenses also rose to $9.5 million compared to $8.0 million in the same period in 2023 due to higher personnel costs and other operational expenses.

Akero's lead product candidate, Efruxifermin (EFX), is an Fc-FGF21 fusion protein designed to mimic the biological activity of native FGF21. EFX aims to alleviate cellular stress, regulate metabolism, reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity, and improve lipid metabolism. This holistic approach could potentially address the complex, multi-system disease state of MASH.

MASH is a serious condition affecting over 17 million Americans, characterized by excessive fat accumulation in the liver, leading to inflammation and fibrosis. This 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 Therapeutics continues to advance its clinical programs, aiming to provide new treatment options for patients with MASH. The company's progress in its Phase 3 SYNCHRONY program and Phase 2b SYMMETRY study marks significant steps towards addressing this high unmet medical need.