Akero Therapeutics Commences Patient Dosing in Key Study

Akero Therapeutics Commences Patient Dosing in Key Study

Outcomes is the third study in the Phase 3 SYNCHRONY clinical trial program

Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company devoted to transforming the treatment of severe metabolic diseases, has commenced dosing in the Phase 3 SYNCHRONY Outcomes trial. This significant milestone marks the initiation of the first patient in a study designed to explore the safety and efficacy of Efruxifermin (EFX) for individuals suffering from compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH).

Understanding the SYNCHRONY Outcomes Trial

The SYNCHRONY program encompasses various studies aimed at addressing the urgent unmet needs in liver conditions associated with MASH. Kitty Yale, chief development officer of Akero, expressed her enthusiasm, stating, "Dosing the first patient in the SYNCHRONY Outcomes trial is a critical step forward. There is a pressing need for therapies that can effectively delay or avert liver failure in MASH patients across different stages of disease. This trial is an exciting opportunity for us to demonstrate the potential of EFX in combating these severe health challenges." 

Significance of Efruxifermin

EFX is pivotal to Akero’s approach to treating liver diseases related to MASH. The drug is designed to replicate the natural biological activities of FGF21, a hormone that plays a vital role in modulating metabolism and alleviating cellular stress. Through this innovative mechanism, EFX aims to tackle symptoms associated with MASH, such as liver fat reduction, inflammation control, and improved insulin sensitivity while being administered conveniently once a week.

Ongoing Global Efforts

In alignment with the SYNCHRONY Outcomes trial, Akero is also involved in two other Phase 3 clinical studies—SYNCHRONY Histology and SYNCHRONY Real-World. The Histology trial is evaluating the effects of EFX on patients with pre-cirrhotic MASH, while the Real-World study focuses on its safety and tolerability in patients diagnosed non-invasively. These trials together aim to build a comprehensive understanding of the treatment’s impact on liver health and overall survival rates in MASH patients.

Patient-Centric Approach to Treatment

Self-administration of EFX is facilitated through the LyoJect 3S dual chamber syringe, which is designed for ease of use should EFX receive market approval. The commitment to patient convenience remains a cornerstone of Akero's strategy, ensuring that emerging treatments are accessible and manageable for patients.

Looking Ahead: Phase 2B SYMMETRY Study

As Akero forges ahead, the company is also anticipating results from the ongoing Phase 2b SYMMETRY trial, which investigates the effectiveness and safety of EFX in patients with compensated cirrhosis due to MASH. These results are projected to be unveiled in the near future, adding to the wealth of knowledge regarding this promising therapy.

The Impact of MASH

MASH represents a critical public health issue, affecting over 17 million individuals in the United States. Its characteristics include excessive liver fat accumulation, resulting in inflammation and potential progression to cirrhosis, liver failure, or cancer. The urgency surrounding MASH is underscored by its status as one of the leading causes of liver transplants and liver cancer in both the US and Europe.

The Vision of Akero Therapeutics

Headquartered in South San Francisco, Akero Therapeutics is committed to developing meaningful solutions for patients with serious metabolic diseases. Their approach is innovative and patient-focused, with EFX currently undergoing extensive evaluations as part of the comprehensive SYNCHRONY program. With the ongoing advancements in these clinical trials, Akero aims to deliver impactful therapies that address the complexities of liver diseases associated with MASH.

Frequently Asked Questions

What is the SYNCHRONY Outcomes trial?

The SYNCHRONY Outcomes trial is part of Akero's Phase 3 clinical program evaluating the safety and efficacy of Efruxifermin in treating compensated cirrhosis due to MASH.

What is Efruxifermin (EFX)?

EFX is a therapeutic candidate designed to mimic the natural activity of FGF21, aimed at reducing liver fat and inflammation while improving insulin sensitivity.

How does the LyoJect 3S syringe work?

The LyoJect 3S dual chamber syringe is a pre-filled device that allows patients to self-administer EFX conveniently, enhancing treatment accessibility.

What are the next steps for Akero Therapeutics?

Akero is actively participating in multiple clinical trials, including the Phase 2b SYMMETRY study, with further results expected shortly.

What challenges does MASH present?

MASH poses significant health risks, leading to conditions such as cirrhosis and liver cancer. Addressing its prevalence is critical for public health, given its severe consequences.

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