Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine
Akero Therapeutics (NASDAQ: AKRO) announced the publication of its Phase 2b SYMMETRY trial results in the New England Journal of Medicine, evaluating efruxifermin (EFX) for treating compensated cirrhosis due to MASH. The 96-week study showed significant fibrosis improvement, with 29% of participants in the EFX 50mg group and 21% in the 28mg group showing improvement compared to 11% in the placebo group.
At week 36, the primary endpoint of ≥1-stage fibrosis improvement without MASH worsening was achieved by 19% and 18% of participants in the 50mg and 28mg groups respectively, versus 13% for placebo. The treatment demonstrated improvements in liver injury markers, insulin sensitivity, and lipid metabolism. Safety profile was consistent with previous trials, with mainly mild to moderate gastrointestinal side effects.
Akero Therapeutics (NASDAQ: AKRO) ha annunciato la pubblicazione dei risultati dello studio di Fase 2b SYMMETRY sul efruxifermin (EFX) per il trattamento della cirrosi compensata dovuta a MASH, sul New England Journal of Medicine. Lo studio di 96 settimane ha mostrato un miglioramento significativo della fibrosi, con il 29% dei partecipanti nel gruppo EFX da 50 mg e il 21% nel gruppo da 28 mg che hanno evidenziato miglioramenti, rispetto all'11% nel gruppo placebo.
Alla settimana 36, l'endpoint primario di un miglioramento della fibrosi di almeno 1 stadio senza peggioramento della MASH è stato raggiunto dal 19% e 18% dei partecipanti nei gruppi da 50 mg e 28 mg rispettivamente, contro il 13% del placebo. Il trattamento ha mostrato miglioramenti nei marcatori di danno epatico, nella sensibilità all'insulina e nel metabolismo lipidico. Il profilo di sicurezza è risultato coerente con studi precedenti, con effetti collaterali principalmente gastrointestinali da lievi a moderati.
Akero Therapeutics (NASDAQ: AKRO) anunció la publicación de los resultados del ensayo de Fase 2b SYMMETRY sobre efruxifermin (EFX) para el tratamiento de la cirrosis compensada causada por MASH, en el New England Journal of Medicine. El estudio de 96 semanas mostró una mejora significativa en la fibrosis, con un 29% de los participantes en el grupo de EFX 50 mg y un 21% en el grupo de 28 mg que mostraron mejoría, en comparación con el 11% en el grupo placebo.
En la semana 36, el objetivo principal de mejora de fibrosis de ≥1 estadio sin empeoramiento de MASH fue alcanzado por el 19% y 18% de los participantes en los grupos de 50 mg y 28 mg respectivamente, frente al 13% del placebo. El tratamiento mostró mejoras en los marcadores de lesión hepática, sensibilidad a la insulina y metabolismo lipídico. El perfil de seguridad fue consistente con ensayos previos, con efectos secundarios gastrointestinales principalmente leves a moderados.
Akero Therapeutics (NASDAQ: AKRO)는 MASH로 인한 보상성 간경변증 치료를 위한 efruxifermin (EFX)의 2b상 SYMMETRY 임상시험 결과를 New England Journal of Medicine에 발표했다고 밝혔습니다. 96주간의 연구에서 섬유증이 유의하게 개선되었으며, EFX 50mg 그룹의 29%, 28mg 그룹의 21% 참가자가 개선을 보였고 이는 위약군의 11%와 비교됩니다.
36주차에 1단계 이상 섬유증 개선 및 MASH 악화 없이 달성한 주요 평가변수는 각각 50mg 그룹에서 19%, 28mg 그룹에서 18%였으며, 위약군은 13%였습니다. 치료는 간 손상 지표, 인슐린 감수성 및 지질 대사 개선을 나타냈습니다. 안전성 프로필은 이전 시험과 일치했으며, 주로 경증에서 중등도의 위장관 부작용이 보고되었습니다.
Akero Therapeutics (NASDAQ: AKRO) a annoncé la publication des résultats de son essai de phase 2b SYMMETRY sur efruxifermin (EFX) pour le traitement de la cirrhose compensée due à la MASH, dans le New England Journal of Medicine. L'étude de 96 semaines a montré une amélioration significative de la fibrose, avec 29 % des participants du groupe EFX 50 mg et 21 % de celui à 28 mg présentant une amélioration, contre 11 % dans le groupe placebo.
À la semaine 36, le critère principal d'amélioration de la fibrose d’au moins un stade sans aggravation de la MASH a été atteint par 19 % et 18 % des participants dans les groupes 50 mg et 28 mg respectivement, contre 13 % pour le placebo. Le traitement a montré des améliorations des marqueurs de lésions hépatiques, de la sensibilité à l'insuline et du métabolisme lipidique. Le profil de sécurité était cohérent avec les essais précédents, avec principalement des effets secondaires gastro-intestinaux légers à modérés.
Akero Therapeutics (NASDAQ: AKRO) gab die Veröffentlichung der Ergebnisse der Phase-2b-SYMMETRY-Studie zu efruxifermin (EFX) zur Behandlung der kompensierten Zirrhose aufgrund von MASH im New England Journal of Medicine bekannt. Die 96-wöchige Studie zeigte eine signifikante Verbesserung der Fibrose, wobei 29 % der Teilnehmer in der EFX 50 mg-Gruppe und 21 % in der 28 mg-Gruppe eine Verbesserung zeigten, verglichen mit 11 % in der Placebogruppe.
In Woche 36 wurde der primäre Endpunkt einer ≥1-Stufen-Fibroseverbesserung ohne Verschlechterung der MASH von 19 % bzw. 18 % der Teilnehmer in den 50 mg- bzw. 28 mg-Gruppen erreicht, gegenüber 13 % im Placebo. Die Behandlung zeigte Verbesserungen bei Leberverletzungsmarkern, Insulinsensitivität und Lipidstoffwechsel. Das Sicherheitsprofil entsprach den vorherigen Studien mit überwiegend milden bis moderaten gastrointestinalen Nebenwirkungen.
- 29% of participants in EFX 50mg group showed fibrosis improvement at week 96, significantly higher than placebo (11%)
- Most participants maintained their response from week 36 to week 96, with additional new responders at week 96
- Treatment showed improvements in liver injury markers, insulin sensitivity, and lipid metabolism
- Safety profile remained consistent with previous trials, with mostly mild to moderate side effects
- Primary endpoint results at week 36 showed modest improvement over placebo (19% vs 13%)
- Gastrointestinal adverse events and injection site reactions were more common in treatment groups
Insights
Akero's 96-week SYMMETRY data shows modest but meaningful fibrosis improvement in cirrhotic MASH patients, with increasing efficacy over time.
The publication of Akero's Phase 2b SYMMETRY trial in the prestigious New England Journal of Medicine represents significant validation for their FGF21 analog efruxifermin (EFX) program. Looking at the primary endpoint data at 36 weeks, the results show only
However, the 96-week data reveals something more compelling: the response rate increased to
What makes these results particularly noteworthy is the patient population studied - those with compensated cirrhosis (F4 fibrosis), representing the most advanced, pre-decompensated form of MASH. Historically, achieving fibrosis improvement in cirrhotic patients has been extremely challenging, making even these modest results potentially meaningful. The drug also demonstrated improvements in non-invasive biomarkers of liver injury, fibrosis, insulin sensitivity, and lipid metabolism.
The safety profile appears manageable, with primarily mild-to-moderate gastrointestinal effects and injection site reactions. Publication in NEJM and presentation at EASL Congress 2025 positions this data favorably in the competitive MASH treatment landscape, while supporting Akero's ongoing Phase 3 SYNCHRONY program.
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,
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
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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