Akero Therapeutics Announces Initiation of Phase 3 SYNCHRONY Outcomes Trial of Efruxifermin in Patients with Compensated Cirrhosis (F4) Due to MASH
Akero Therapeutics has initiated the SYNCHRONY Outcomes Phase 3 trial to evaluate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to MASH. This trial, which will enroll patients globally, aims to assess the efficacy and safety of EFX. The primary histology endpoint is fibrosis regression without worsening MASH after 96 weeks, and the primary outcomes endpoint is all-cause mortality and liver-related clinical outcomes.
The SYNCHRONY program includes three trials: Histology, Real-World, and Outcomes, each focused on different stages of MASH. EFX will be administered via the LyoJect 3S dual chamber syringe, a device designed for self-administration.
- Initiation of a Phase 3 trial indicates progress in clinical development.
- Encouraging results from the previous Phase 2b SYMMETRY study.
- Potential for EFX to be among the first approved treatments for both pre-cirrhotic and cirrhotic MASH patients.
- Global, randomized, placebo-controlled trial design increases the credibility of the study.
- Inclusion of secondary endpoints for comprehensive outcome measurement.
- LyoJect 3S syringe allows for convenient self-administration, enhancing patient compliance.
- Extended timeline of 96 weeks for primary histology endpoint could delay results and potential approval.
- Dependency on long-term clinical outcomes data, which may introduce risks if results are unfavorable.
- Recruitment challenges for a global trial may delay study completion.
- The need for a placebo-controlled group means some patients will not receive the potentially beneficial treatment.
The initiation of the Phase 3 SYNCHRONY Outcomes trial represents a significant milestone for Akero Therapeutics and the field of metabolic diseases. This trial's focus on patients with compensated cirrhosis due to MASH (Metabolic Dysfunction-Associated Steatohepatitis) addresses a high unmet medical need as these patients are at increased risk of severe liver-related complications, including liver failure and hepatocellular carcinoma.
One of the primary endpoints of the trial, fibrosis regression without worsening of MASH, is particularly critical. Fibrosis regression indicates a reversal or halting of liver damage, which could dramatically alter the prognosis for these patients, potentially reducing the risk of progression to more severe liver diseases.
Moreover, the trial includes secondary endpoints such as changes in non-invasive markers of liver injury, glycemic control and lipids, offering a comprehensive assessment of EFX's impact. This holistic approach could provide deeper insights into the drug’s mechanism of action and benefits beyond liver health, potentially positioning EFX as a multi-faceted treatment option.
For retail investors, understanding the clinical significance of fibrosis regression and the broader implications of secondary endpoints is crucial. If successful, EFX could become one of the first approved treatments for both pre-cirrhotic and cirrhotic patients, representing a substantial market opportunity and likely driving Akero's stock performance positively in the long term.
From a financial perspective, the initiation of a Phase 3 trial is a pivotal moment for a clinical-stage biotech company like Akero Therapeutics. The trial's success could lead to FDA approval and commercialization, significantly impacting the company's financial health and valuation.
Investors should note the scale of the SYNCHRONY program, which includes three global, randomized, placebo-controlled clinical trials. This indicates a substantial investment in R&D and commitment to bringing EFX to market. The use of the LyoJect 3S dual chamber syringe for self-administration also suggests that Akero is preparing for a streamlined path to commercialization, potentially reducing manufacturing and distribution complexities.
However, it is important to consider the risks associated with such trials. Phase 3 outcomes are critical and any negative results could adversely affect the stock price. Additionally, the cost of running these trials could strain financial resources if not managed effectively.
In the short term, the market might react positively to the initiation news, but long-term investor sentiment will hinge on the trial's results and subsequent regulatory approvals. The broader market potential for a first-in-class treatment for both pre-cirrhotic and cirrhotic patients could make Akero a compelling investment, provided the company navigates the clinical and regulatory hurdles successfully.
SOUTH SAN FRANCISCO, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced initiation of the SYNCHRONY Outcomes study, a Phase 3 trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis, fibrosis stage 4 (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).
“Patients with compensated cirrhosis represent the greatest unmet need among MASH patients due to increased risk of progression to liver failure, hepatocellular carcinoma or death,” said Kitty Yale, chief development officer of Akero. “Based on the encouraging week 36 results of our Phase 2b SYMMETRY study in patients with compensated cirrhosis due to MASH, we believe EFX has the potential to be among the first investigational drugs to be approved for treatment of both pre-cirrhotic and cirrhotic patients.”
SYNCHRONY Outcomes, a global, randomized, placebo-controlled, 2-cohort, Phase 3 trial, is actively recruiting patients with compensated cirrhosis (F4) due to MASH to receive weekly injections of EFX 50mg or placebo. The primary histology endpoint (Cohort 1 only) is fibrosis regression without worsening of MASH after 96 weeks of treatment based on histology, after which patients will continue treatment as randomized to be evaluated for the primary outcomes endpoint. The primary outcomes endpoint is all-cause mortality and liver-related clinical outcomes as measured by time to first occurrence of any of the pre-defined, adjudicated events across both study cohorts (Cohorts 1 and 2). Key secondary endpoints for the Outcomes study include changes from baseline in non-invasive markers of liver injury and fibrosis, glycemic control and lipids.
Phase 3 SYNCHRONY Program
Akero’s Phase 3 SYNCHRONY program is comprised of three ongoing global, randomized, placebo-controlled clinical trials: SYNCHRONY Histology, Real-World, and Outcomes. SYNCHRONY Histology and Real-World are respectively investigating EFX in patients with pre-cirrhotic MASH (F2-F3 fibrosis), and patients with MASH (F1-F3 fibrosis) or metabolic dysfunction-associated steatotic liver disease (MASLD). SYNCHRONY Outcomes is evaluating EFX in patients with compensated cirrhosis due to MASH (F4 fibrosis). In all EFX Phase 3 studies, patients are using the LyoJect 3S dual chamber syringe, a pre-filled device designed for self-administration and intended for commercial use in the event EFX is approved for marketing. This optimized formulation delivers blood levels of EFX comparable to those of the liquid formulation used in prior clinical studies.
About Efruxifermin
Efruxifermin (EFX), Akero’s lead product candidate for MASH, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipids. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in MASH patients. EFX is designed to offer convenient once-weekly dosing and has been generally well tolerated in clinical trials to date.
About MASH
MASH is a serious form of MASLD that is estimated to affect more than 17 million Americans. MASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH or compensated cirrhosis due to MASH: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. The SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY study in patients with compensated cirrhosis due to MASH (F4). Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and Twitter for more information.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX; the SYNCHRONY Phase 3 program clinical trial design; and the therapeutic effects of EFX as well as the dosing, safety and tolerability of EFX. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Christina Tartaglia
212.362.1200
IR@akerotx.com
Media Contact:
Peg Rusconi
617.910.6217
peg.rusconi@vergescientific.com
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