Akero Therapeutics Presents New Analyses from Phase 2b SYMMETRY and HARMONY Trials of Efruxifermin at 76th Annual AASLD The Liver Meeting® 2025
Akero Therapeutics (NASDAQ: AKRO) presented new analyses from 96-week Phase 2b SYMMETRY and HARMONY trials of efruxifermin at AASLD 2025 (Nov 7-11, 2025). Post-hoc and AI-assisted digital pathology analyses corroborated prior conventional-pathology findings, reporting antifibrotic activity, reductions in total fibrosis and septa area, and statistically significant improvements in noninvasive measures linked to lower risk of liver-related events and clinically significant portal hypertension (CSPH) in compensated cirrhosis (F4c).
Four presentations (two oral, two posters) detail these results and timing: SYMMETRY and HARMONY data are being further validated in the company’s ongoing Phase 3 program.
Akero Therapeutics (NASDAQ: AKRO) ha presentato nuove analisi dai trial di fase 2b SYMMETRY e HARMONY a 96 settimane di efruxifermin all'AASLD 2025 (7-11 novembre 2025). Le analisi post-hoc e AI-assisted digital pathology hanno corroborato i precedenti rilievi di patologia convenzionale, riportando attività antifibrotica, riduzioni dell'area totale di fibrosi e dei setti, e miglioramenti statisticamente significativi in misure non invasive legate a un minor rischio di eventi correlati al fegato e a una CSPH clinicamente significativa (CSPH) in cirrosi compensata (F4c).
Quattro presentazioni (due orali, due poster) dettagliano questi risultati e la tempistica: i dati SYMMETRY e HARMONY sono ulteriormente convalidati nel programma di fase 3 in corso dell'azienda.
Akero Therapeutics (NASDAQ: AKRO) presentó nuevos análisis de 96 semanas de los ensayos de fase 2b SYMMETRY y HARMONY de efruxifermin en AASLD 2025 (7-11 de noviembre de 2025). Análisis post-hoc y de patología digital asistida por IA corroboraron los hallazgos previos de patología convencional, reportando actividad antifibrotica, reducciones en el área total de fibrosis y de los septos, y mejoras estadísticamente significativas en medidas no invasivas vinculadas a un menor riesgo de eventos hepáticos y a una hipertensión portal clínicamente significativa (CSPH) en cirrosis compensada (F4c).
Cuatro presentaciones (dos orales, dos pósteres) detallan estos resultados y su cronología: los datos de SYMMETRY y HARMONY están siendo validados adicionalmente en el programa de fase 3 en curso de la empresa.
Akero Therapeutics (NASDAQ: AKRO)는 efruxifermin의 96주 차 Phase 2b SYMMETRY 및 HARMONY 임상에서의 새로운 분석을 2025년 AASLD에서 발표했습니다(2025년 11월 7-11일). 포스트호크(post-hoc) 및 AI 보조 디지털 병리 분석은 기존의 일반 병리 소견을 보강하며 섬유화 억제 활성, 전체 섬유화 및 간소폭 면적 감소, 간 관련 사건의 위험 감소와 임상적으로 중요한 간문맥고혈압(CSPH)과 관련된 비침습 지표에서 통계적으로 유의한 개선을 보고했습니다(보상 간경변(F4c)).
네 가지 발표(두 구두, 두 포스터)가 이러한 결과와 시기에 대해 자세히 다루며, SYMMETRY 및 HARMONY 데이터는 회사의 진행 중인 3상 프로그램에서 추가로 확인되고 있습니다.
Akero Therapeutics (NASDAQ: AKRO) a présenté de nouvelles analyses sur 96 semaines des essais de phase 2b SYMMETRY et HARMONY de efruxifermin à l'AASLD 2025 (7-11 novembre 2025). Des analyses post-hoc et de pathologie numérique assistée par IA ont corroboré les résultats antérieurs de pathologie conventionnelle, rapportant une activité antifibrotique, des réductions de la fibrose totale et de la surface des septa, et des améliorations statistiquement significatives dans des mesures non invasives liées à un risque moindre d'événements hépatiques et à une hypertension portale cliniquement significative (CSPH) chez la cirrhose compensée (F4c).
Quatre présentations (deux orales, deux posters) décrivent ces résultats et leur chronologie: les données SYMMETRY et HARMONY sont en cours de validation supplémentaire dans le programme de phase 3 en cours de l'entreprise.
Akero Therapeutics (NASDAQ: AKRO) präsentierte neue Analysen aus den 96-wöchigen Phase-2b-Studien SYMMETRY und HARMONY von efruxifermin auf der AASLD 2025 (7.–11. November 2025). Post-hoc- und KI-gestützte digitale Pathologie-Analysen untermauerten frühere konventionelle Pathologiebefunde, berichteten über antifibrotische Aktivität, Reduktionen der Gesamtsfibrose und der Septenfläche sowie statistisch signifikante Verbesserungen in nicht-invasiven Messgrößen, die mit einem geringeren Risiko leberbezogener Ereignisse und klinisch signifikanter portaler Hypertension (CSPH) bei kompensierter Zirrhose (F4c) verbunden sind.
Vier Präsentationen (zwei mündliche, zwei Poster) erläutern diese Ergebnisse und deren Zeitplan: SYMMETRY- und HARMONY-Daten werden im laufenden Phase-3-Programm des Unternehmens weiter validiert.
Akero Therapeutics (NASDAQ: AKRO) قدمت تحليلات جديدة من تجارب المرحلة 2b التي استمرت 96 أسبوعاً SYMMETRY و HARMONY لـ efruxifermin في AASLD 2025 (7-11 نوفمبر 2025). التحليلات ما بعد الحدث والتحليلات الرقمية لل病理 بمساعدة الذكاء الاصطناعي أكدت نتائج علم الأمراض التقليدية السابقة، موضحةً وجود نشاط مضاد لتليف الكبد، وتخفيضات في إجمالي التليف ومساحة الفواصل، وتحسينات ذات دلالة إحصائية في مقاييس غير جراحية مرتبطة بانخفاض مخاطر الأحداث المرتبطة بالكبد وارتفاع ضغط الدم البابي السريري (CSPH) في التليف الكبدي المعوض (F4c).
أربعة عروض تقديمية (اثنان شفهيان، اثنان ملصقان) توضح هذه النتائج وتوقيتها: يتم حالياً التحقق من صحة بيانات SYMMETRY وHARMONY في برنامج الشركة من المرحلة 3 الجاري.
- Statistically significant improvements in CSPH risk by Baveno criteria
- AI pathology showed reduced total fibrosis and septa area in SYMMETRY
- HARMONY AI analysis corroborated fibrosis improvements in F2–F3 MASH
- Findings cover 96-week, placebo-controlled Phase 2b data
- Key analyses are post-hoc, limiting prospective strength of findings
- Phase 3 validation ongoing; Phase 2b results not definitive for approval
Insights
New analyses show consistent antifibrotic signals for efruxifermin across 96-week SYMMETRY and HARMONY datasets.
The data describe statistically significant improvements in noninvasive tests linked to fibrosis regression and reduced clinically significant portal hypertension (CSPH) risk by Baveno criteria in the 96-week SYMMETRY cohort with compensated cirrhosis (F4c). Quantitative AI-assisted digital pathology (HistoIndex and PathAI) corroborated conventional histology and reported reductions in total fibrosis and septa area, which are concrete tissue-level measures tied to cirrhosis severity.
These findings strengthen the chain of evidence that the drug produced histologic and noninvasive changes over 96 weeks. Key dependencies include the post-hoc nature of some analyses and the need to confirm clinical benefit (reduced liver-related events) in ongoing prospective studies. Watch the oral presentations on
Corroborating histology and noninvasive improvements at 96 weeks supports continued Phase 3 validation of efruxifermin.
The company reports concordant results across independent analytic approaches: conventional pathology, AI-assisted digital pathology (HistoIndex), and an AI-powered histology platform (PathAI). Concordance across modalities reduces the risk that a single-method artifact explains the fibrosis changes and supports regulatory-grade evidence generation when combined with prospective endpoints.
Risks remain: several analyses are post-hoc and require pre-specified confirmation; regulatory assessment will hinge on hard clinical outcomes and pre-specified endpoints in the ongoing Phase 3 program. Monitor the detailed presentation slides and statistics from AASLD on
Post-hoc analyses corroborate previously reported antifibrotic effects of efruxifermin observed in 96-week Phase 2b SYMMETRY trial and indicate potential to reduce risk of disease progression in compensated cirrhosis (F4c) due to MASH
Digital pathology reinforces fibrosis improvements observed through conventional pathology in the 96-week Phase 2b HARMONY trial
SOUTH SAN FRANCISCO, Calif., Nov. 07, 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 new findings from the SYMMETRY and HARMONY Phase 2b trials of efruxifermin in patients with compensated cirrhosis (F4c) due to metabolic dysfunction-associated steatohepatitis (MASH) and pre-cirrhotic (F2-F3) MASH, respectively. The data will be shared during two oral and two poster presentations at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025, taking place November 7-11, 2025, in Washington, D.C.
“Patients with cirrhosis due to MASH are at a high risk for hepatic decompensation and development of life-threatening complications. The results we are presenting at AASLD bolster our confidence in the potential of efruxifermin to provide a meaningful and differentiated therapeutic option for F4c and earlier stages of MASH,” said Kitty Yale, chief development officer of Akero Therapeutics. “Efruxifermin has consistently demonstrated clear antifibrotic activity in clinical trials. These new analyses provide further evidence of fibrosis reversal and reduced risk of disease progression with efruxifermin in patients with MASH, which is being validated in our ongoing Phase 3 clinical trial program.”
New post-hoc analyses of 96-week data from the SYMMETRY trial reinforce the antifibrotic activity of efruxifermin in F4c MASH:
- Efruxifermin was associated with statistically significant improvements in clinically significant portal hypertension (CSPH) risk, as assessed by Baveno criteria. CSPH, a serious complication of cirrhosis, increases risk of hepatic complications.
- Significantly more participants treated with efruxifermin vs. placebo met thresholds for clinically meaningful improvements in noninvasive measures of fibrosis that predict reduced risk of liver-related events.
- Evaluation of liver biopsies from SYMMETRY using AI-assisted digital pathology (HistoIndex) corroborated the fibrosis improvements previously demonstrated by conventional pathology and revealed that efruxifermin consistently reduced total fibrosis and septa area, key features of cirrhosis related to disease severity.
Additionally, an AI-powered digital pathology analysis (PathAI) of liver biopsies from the 96-week HARMONY trial in participants with F2/F3 MASH corroborated the previously reported fibrosis improvements shown by conventional pathology, providing further support for the improvements in fibrosis and MASH observed with efruxifermin.
Details for the presentations are as follows:
Oral Presentations
Title: Efruxifermin was associated with improvements in multiple non-invasive tests indicative of fibrosis regression in participants with compensated cirrhosis due to MASH (SYMMETRY)
Presenter: Vlad Ratziu
Session: Clinical Plenary #1
Date/Time: Sunday, November 9, 2025, 12:00 PM ET
Title: Efruxifermin improved markers of portal hypertension as evaluated by Baveno VII criteria in compensated cirrhosis due to MASH: results from a 96-week, placebo-controlled, phase 2b trial
Presenter: Mazen Noureddin
Session: MASH Clinical Trials
Date/Time: Sunday, November 9, 2025, 2:45 PM ET
Poster Presentations
Title: Efruxifermin reduced fibrosis and septa area by quantitative digital pathology in participants with compensated cirrhosis due to MASH: Results from the 96-week, placebo-controlled, phase 2b SYMMETRY trial
Presenter: Mary E. Rinella
Session: Late Breaking Poster Session
Date/Time: Saturday, November 8, 2025
Title: AI-powered histology analysis of HARMONY reveals Efruxifermin-driven changes in the liver microarchitecture in F2/F3 MASH
Presenter: Jörn M. Schattenberg
Session: MASLD/MASH Therapeutics: New Agents and Approved / Available Agents
Date/Time: Monday, November 10, 2025
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, is currently being evaluated in three ongoing Phase 3 clinical trials: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4c) 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 trial in patients with pre-cirrhotic MASH and the SYMMETRY trial 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.
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 therapeutic effects, reduced risk of disease progression and anti-fibrotic activity 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 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.
Investor Contact:
Christina Tartaglia
Precision AQ
212.362.1200
IR@akerotx.com
Media Contact:
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Deerfield Group
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FAQ
What did Akero announce about efruxifermin results at AASLD 2025 for AKRO?
How did efruxifermin affect clinically significant portal hypertension (CSPH) in the SYMMETRY trial (AKRO)?
Do the SYMMETRY and HARMONY results use conventional or AI pathology for AKRO data?
When and where were the AKRO efruxifermin presentations scheduled at AASLD 2025?
Do the SYMMETRY/HARMONY Phase 2b findings mean efruxifermin is approved for MASH (AKRO)?
