Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine
Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025
SOUTH SAN FRANCISCO, Calif., May 09, 2025 (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 publication of results from the Phase 2b SYMMETRY trial in the New England Journal of Medicine.
The publication reports results from the 96-week SYMMETRY study evaluating the efficacy and safety of Akero's lead FGF21 analog efruxifermin (EFX), in participants with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis (MASH).
"Publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine is a significant milestone that affirms the strength of our clinical data and the potentially transformative nature of EFX in the treatment of patients with compensated cirrhosis due to MASH," said Kitty Yale, chief development officer of Akero. "We remain encouraged by the potential benefits of treatment with EFX observed in the study, including unprecedented fibrosis improvement in patients with compensated cirrhosis due to MASH after 96 weeks of treatment, and look forward to continuing advancement of our ongoing Phase 3 SYNCHRONY program."
The primary endpoint was ≥1-stage fibrosis improvement without MASH worsening at 36 weeks of treatment, with secondary outcomes of fibrosis improvement without MASH worsening at week 96 and MASH resolution at weeks 36 and 96. Using an intent-to-treat (ITT) analysis of the 36 week results, for which participants with missing biopsies were included as non-responders, 19% of participants in the EFX 50mg group and 18% of participants in the EFX 28mg group met the primary endpoint, compared to 13% for placebo. At week 96, using the same ITT analysis, 29% of participants in the EFX 50mg group and 21% of participants in the EFX 28mg group had fibrosis improvement without MASH worsening, compared to 11% in the placebo group. Most participants in the EFX groups with a fibrosis improvement at week 36 appeared to maintain their response at week 96, with additional new responders observed at week 96, particularly for the EFX 50mg group.
EFX was also associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared with placebo at week 96.
The safety and tolerability of EFX observed in the SYMMETRY trial was consistent with previous trials. Observed adverse events, more common with EFX than placebo, were primarily gastrointestinal (e.g., diarrhea and nausea) or injection site related, with the majority being mild or moderate and transient in nature.
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 metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information.
About MASH
MASH is a serious form of MASLD that is estimated to affect 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. Approximately 20% of patients with MASH will progress to cirrhosis, which has a higher risk of mortality. There are no approved treatments for the condition and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About Cirrhosis Due to MASH
Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer, and death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe.
About the SYMMETRY Trial
SYMMETRY was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study randomized 182 patients, and 181 received once-weekly subcutaneous EFX 28mg or 50mg, or placebo for 96 weeks. The primary efficacy endpoint was the proportion of patients with ≥1-stage fibrosis improvement without worsening of MASH at Week 36. Secondary efficacy measures at Week 96 included ≥1 stage fibrosis improvement without worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, serum markers of glucose and lipid metabolism, as well as safety and tolerability measures.
About EFX
Efruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
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; the potential transformative nature and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the future potential and long-term benefits of EFX following the preliminary topline week 96 results of Akero's Phase 2b SYMMETRY study; and the ongoing SYNCHRONY Phase 3 program,. 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 any of its clinical studies 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.
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