Akero Therapeutics Q2 2024 Financial Results and Business Update

Akero Therapeutics, a clinical-stage firm focused on breakthrough treatments for serious metabolic diseases, reported significant advances and second-quarter 2024 financial results. Among the noteworthy developments, the company initiated the Phase 3 SYNCHRONY Outcomes trial, presented crucial findings at the EASL Congress 2024, and appointed a new Chief Technical Officer (CTO).

Key Developments in Clinical Trials

Initiation of Phase 3 SYNCHRONY Outcomes Trial

Akero has begun the SYNCHRONY Outcomes trial, part of its Phase 3 SYNCHRONY clinical program, which includes three global, randomized, placebo-controlled studies. These trials aim to support marketing applications for therapies targeting compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) and pre-cirrhotic MASH.

The SYNCHRONY Outcomes trial recruits patients with compensated cirrhosis (F4) due to MASH, administering weekly injections of Efruxifermin (EFX) 50mg or placebo. The primary endpoint for Cohort 1 is fibrosis regression without MASH worsening after 96 weeks. Long-term primary outcomes will be evaluated across both cohorts.

The SYNCHRONY Histology trial involves patients with pre-cirrhotic MASH (F2-F3), receiving weekly injections of EFX 28mg, 50mg, or placebo. The trial aims for accelerated approval by gauging fibrosis improvement and MASH resolution after 52 weeks. Long-term outcomes will continue to be monitored post-52 weeks.

Lastly, the SYNCHRONY Real-World trial assesses safety and tolerability in patients with MASH or MASLD, with weekly injections of EFX 50mg or placebo. These trials anticipate using the LyoJect 3S dual chamber syringe for potential commercial use if EFX gains approval.

Presentations at EASL Congress 2024

In June 2024, Akero presented data from the Phase 2b HARMONY study at the European Association for the Study of the Liver (EASL) Congress. The late-breaking presentation showcased 96-week data demonstrating promising results: 75% of patients on 50mg EFX showed a one-stage improvement in fibrosis without MASH worsening, compared to 24% for placebo.

Further analysis revealed significant fibrosis improvement even in patients with advanced F3 fibrosis, with improvements deepening over time, especially in the 50mg EFX group. The treatment was generally well tolerated, with no severe adverse events, deaths, or liver decompensation.

A poster presentation at the same congress highlighted post-hoc analysis of biomarkers related to collagen synthesis and degradation after 24 weeks of EFX treatment, indicating beneficial tissue remodeling and reduction in liver injury markers.

Leadership Expansion

In April 2024, Akero appointed Scott Gangloff as Chief Technical Officer, enhancing its leadership team. Gangloff's expertise will bolster Akero’s manufacturing capabilities and supply chain optimization for EFX, supporting its potential commercial launch.

Ongoing Phase 2b SYMMETRY Study

Akero's Phase 2b SYMMETRY study, evaluating EFX’s efficacy and safety in patients with compensated cirrhosis due to MASH (F4), is on track to report 96-week results in early 2025.

Financial Performance

For the second quarter ending June 30, 2024, Akero reported $848.3 million in cash, cash equivalents, and marketable securities. Research and development expenses rose to $55.3 million from $28.0 million in the same period in 2023, driven by ongoing and new trials and personnel costs. General and administrative expenses increased to $10.4 million, attributed to higher personnel and operational costs. The total operating expenses for the quarter were $65.7 million, nearly doubling from $35.6 million in the previous year.

Efruxifermin (EFX)

Efruxifermin, Akero’s lead candidate for MASH, is an Fc-FGF21 fusion protein designed to mimic the beneficial properties of native FGF21. It aims to reduce liver fat and inflammation, reverse fibrosis, and enhance metabolic health, offering a holistic approach to treating MASH. EFX has shown to be well tolerated, with convenient once-weekly dosing.

About MASH

MASH is a severe form of MASLD, affecting over 17 million Americans. Characterized by excessive liver fat, inflammation, and fibrosis, MASH can lead to cirrhosis, liver failure, and cancer. It is the fastest-growing cause of liver transplants and cancer in the US and Europe.

About Akero Therapeutics

Headquartered in South San Francisco, Akero Therapeutics is advancing treatments for metabolic diseases with high unmet needs, particularly MASH. The company’s lead product, EFX, is under evaluation in multiple Phase 2b and Phase 3 clinical trials, showing promising results in combating liver fibrosis and associated metabolic dysfunctions.

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