Akero Therapeutics Completes Enrollment of the Double-Blind Portion of the Phase 3 SYNCHRONY Real-World Study Evaluating Efruxifermin (EFX) in Patients with Non-Invasively Diagnosed MASH or MASLD
Akero Therapeutics has completed enrollment of the double-blind portion of its Phase 3 SYNCHRONY Real-World study, focusing on the safety and tolerability of Efruxifermin (EFX) in patients with MASH or MASLD. A total of 601 patients have been enrolled since the study's initiation in November 2023. The study assesses the safety and tolerability of EFX, administered once-weekly in 50mg doses, over 52 weeks.
The SYNCHRONY Real-World study is a randomized, double-blind, placebo-controlled trial, with primary endpoints on safety and tolerability. Secondary endpoints include changes in non-invasive markers of liver fibrosis and injury, as well as lipoproteins, glycemic control, and body weight. An open-label cohort includes patients previously assigned to placebo in Phase 2b studies. Data from this study are expected in the first half of 2026.
Akero's Chief Development Officer, Kitty Yale, noted the rapid enrollment as indicative of the significant need for MASH treatments and optimism surrounding EFX's potential. Previous Phase 2 studies have shown improvements in liver histology and non-invasive liver health markers.
Akero Therapeutics ha completato l'arruolamento della parte in doppio cieco del suo studio di Fase 3 SYNCHRONY Real-World, concentrandosi sulla sicurezza e tollerabilità di Efruxifermin (EFX) in pazienti con MASH o MASLD. Un totale di 601 pazienti sono stati arruolati dall'inizio dello studio nel novembre 2023. Lo studio valuta la sicurezza e la tollerabilità di EFX, somministrato settimanalmente in dosi di 50mg, per un periodo di 52 settimane.
Lo studio SYNCHRONY Real-World è un trial randomizzato, in doppio cieco e controllato con placebo, con obiettivi primari sulla sicurezza e tollerabilità. Gli obiettivi secondari includono cambiamenti nei marcatori non invasivi di fibrosi e danno epatico, così come dei lipoproteine, controllo glicemico e peso corporeo. Una coorte in aperto include pazienti precedentemente assegnati al gruppo placebo negli studi di Fase 2b. I dati di questo studio sono attesi nella prima metà del 2026.
Il Chief Development Officer di Akero, Kitty Yale, ha notato che il rapido arruolamento è indicativo dell'importante bisogno di trattamenti per MASH e dell'ottimismo riguardo al potenziale di EFX. I precedenti studi di Fase 2 hanno mostrato miglioramenti nella istologia epatica e nei marcatori di salute epatica non invasivi.
Akero Therapeutics ha completado el reclutamiento de la parte a doble ciego de su estudio de Fase 3 SYNCHRONY Real-World, centrado en la seguridad y tolerabilidad de Efruxifermin (EFX) en pacientes con MASH o MASLD. Un total de 601 pacientes han sido reclutados desde el inicio del estudio en noviembre de 2023. El estudio evalúa la seguridad y tolerabilidad de EFX, administrado semanalmente en dosis de 50 mg, durante 52 semanas.
El estudio SYNCHRONY Real-World es un ensayo aleatorio, doble ciego y controlado con placebo, con objetivos primarios en seguridad y tolerabilidad. Los objetivos secundarios incluyen cambios en marcadores no invasivos de fibrosis e injuria hepática, así como lipoproteínas, control glucémico y peso corporal. Una cohorte a etiqueta abierta incluye a pacientes que previamente fueron asignados al placebo en estudios de Fase 2b. Se esperan datos de este estudio en la primera mitad de 2026.
La Directora de Desarrollo de Akero, Kitty Yale, señaló que el reclutamiento rápido indica una necesidad significativa de tratamientos para MASH y optimismo sobre el potencial de EFX. Estudios anteriores de Fase 2 han mostrado mejoras en la histología hepática y en los marcadores de salud hepática no invasivos.
Akero Therapeutics는 MASH 또는 MASLD 환자에서 Efruxifermin (EFX)의 안전성과 내약성을 조사하는 3상 SYNCHRONY Real-World 연구의 이중 맹검 부분 참여를 완료했습니다. 2023년 11월 연구 시작 이후 총 601명의 환자가 등록되었습니다. 이 연구는 52주 동안 주 1회 50mg 용량으로 EFX의 안전성과 내약성을 평가합니다.
SYNCHRONY Real-World 연구는 안전성 및 내약성에 대한 주요 목표를 가진 무작위 이중 맹검 위약 대조 시험입니다. 부차적인 목표로는 비침습적 간 섬유증 및 손상 마커의 변화, 지질단백질, 혈당 조절 및 체중 변화가 포함됩니다. 공개 연계된 집단은 2b 단계 연구에서 이전에 위약 그룹에 할당된 환자들을 포함합니다. 이 연구의 데이터는 2026년 상반기에 발표될 예정입니다.
Akero의 최고 개발 책임자 Kitty Yale은 빠른 등록이 MASH 치료에 대한 필수적인 수요와 EFX의 잠재력에 대한 낙관을 나타낸다고 언급했습니다. 이전 2상 연구에서는 간 조직학 및 비침습적 간 건강 지표의 개선이 나타났습니다.
Akero Therapeutics a terminé le recrutement de la partie en double aveugle de son étude de Phase 3 SYNCHRONY Real-World, axée sur la sécurité et la tolérance de l'Efruxifermin (EFX) chez des patients atteints de MASH ou de MASLD. Un total de 601 patients ont été recrutés depuis le début de l'étude en novembre 2023. L'étude évalue la sécurité et la tolérance de l'EFX, administré une fois par semaine à des doses de 50 mg, sur une période de 52 semaines.
L'étude SYNCHRONY Real-World est un essai randomisé, en double aveugle et contrôlé par placebo, avec des objectifs principaux sur la sécurité et la tolérance. Les objectifs secondaires incluent des changements dans les marqueurs non invasifs de la fibrose et des lésions hépatiques, ainsi que des lipoprotéines, le contrôle glycémique et le poids corporel. Une cohorte en ouvert inclut des patients précédemment assignés au placebo lors d'études de Phase 2b. Les données de cette étude sont attendues dans la première moitié de 2026.
Kitty Yale, Directrice du développement chez Akero, a souligné que le recrutement rapide témoigne d'un besoin significatif de traitements pour le MASH et d'un optimisme quant au potentiel de l'EFX. Les études de Phase 2 précédentes ont montré des améliorations dans l'histologie hépatique et les marqueurs de santé hépatique non invasifs.
Akero Therapeutics hat die Rekrutierung des doppelblinden Teils seiner Phase-3-Studie SYNCHRONY Real-World abgeschlossen, die sich auf die Sicherheit und Verträglichkeit von Efruxifermin (EFX) bei Patienten mit MASH oder MASLD konzentriert. Seit Beginn der Studie im November 2023 wurden insgesamt 601 Patienten rekrutiert. Die Studie bewertet die Sicherheit und Verträglichkeit von EFX, das einmal wöchentlich in Dosen von 50 mg über einen Zeitraum von 52 Wochen verabreicht wird.
Die SYNCHRONY Real-World-Studie ist eine randomisierte, doppelblinde, placebo-kontrollierte Studie mit primären Endpunkten zur Sicherheit und Verträglichkeit. Sekundäre Endpunkte umfassen Veränderungen in nicht-invasiven Markern für Leberfibrose und -schädigung sowie Lipoproteine, glykämische Kontrolle und Körpergewicht. Eine offen durchgeführte Kohorte umfasst Patienten, die in Phase-2b-Studien zuvor dem Placebo zugewiesen wurden. Mit Daten aus dieser Studie wird in der ersten Hälfte des Jahres 2026 gerechnet.
Kitty Yale, Chief Development Officer von Akero, bemerkte die schnelle Rekrutierung als Hinweis auf den erheblichen Bedarf an MASH-Behandlungen und Optimismus hinsichtlich des Potenzials von EFX. Frühere Phase-2-Studien zeigten Verbesserungen der Leberhistologie und nicht-invasiven Lebergesundheitsmarkern.
- Completion of enrollment for the Phase 3 SYNCHRONY Real-World study with 601 patients.
- Anticipated data release in the first half of 2026.
- Strong Phase 2 data showing improvements in liver histology and non-invasive markers.
- Data from the SYNCHRONY Real-World study will not be available until the first half of 2026, indicating a long wait for potential market impact.
Insights
The completion of enrollment for SYNCHRONY Real-World's double-blind portion marks a critical milestone in EFX's development pathway. The rapid enrollment of 601 patients in just over a year demonstrates exceptional operational efficiency and strong investigator interest. The study's broad inclusion criteria (F1-F4 fibrosis stages) and non-invasive diagnosis approach significantly differentiate it from traditional MASH trials, potentially accelerating the path to market.
The trial design, incorporating both safety/tolerability primary endpoints and comprehensive secondary endpoints (liver fibrosis markers, metabolic parameters), will provide valuable real-world evidence. The inclusion of previous placebo patients from Phase 2 studies in an open-label cohort adds longitudinal data value. This positions EFX competitively in the rapidly evolving MASH treatment landscape.
This development significantly strengthens Akero's market position in the $15 billion MASH treatment market. The rapid enrollment pace suggests strong physician interest and potential future adoption. The real-world study design, particularly allowing non-invasive diagnosis, aligns with clinical practice patterns and could facilitate broader market penetration post-approval.
The comprehensive endpoint assessment, including metabolic parameters beyond liver health, positions EFX as a potential first-line therapy for MASH/MASLD. With data expected in H1 2026, Akero is well-positioned in the race against competitors. For investors, this milestone reduces operational risk and provides a clear catalyst timeline.
-- 601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 --
-- Data from SYNCHRONY Real-World study anticipated in the first half of 2026 --
SOUTH SAN FRANCISCO, Calif., Jan. 13, 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 it has completed enrollment of patients in the double-blind portion of the Phase 3 SYNCHRONY Real-World study of EFX in patients with metabolic dysfunction-associated steatohepatits (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4).
This Real-World study is evaluating the safety and tolerability of EFX in a double-blind cohort of 601 patients with MASH and MASLD.
“Completion of enrollment in the double-blind portion of the SYNCHRONY Real-World study in just over a year is a testament to the significant need for differentiated MASH treatments and growing enthusiasm around EFX’s development,” said Kitty Yale, chief development officer. “We are encouraged by the strength of data across our Phase 2 studies, in which improvements in liver histology and multiple non-invasive markers of liver health have been observed. We look forward to reporting results from SYNCHRONY Real-World – our first Phase 3 results – in the first half of next year.”
SYNCHRONY Real-World is a Phase 3 randomized, double-blind, placebo controlled study evaluating the safety and tolerability of EFX in patients with suspected or confirmed clinical diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD, fibrosis stages F1-F4. The study includes an open-label cohort of patients previously assigned to placebo in the Phase 2b HARMONY or SYMMETRY studies. Enrolled patients are receiving once-weekly subcutaneous dosing of either 50mg EFX or placebo. Primary endpoints for the blinded portion of the study include assessments of the safety and tolerability of EFX during 52 weeks of treatment. Secondary endpoints for the blinded portion of the study include changes from baseline in non-invasive markers of liver fibrosis and liver injury, as well as lipoproteins, glycemic control, and body weight.
Results from the SYNCHRONY Real-World study are anticipated in the first half of 2026.
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 lipid metabolism. 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 three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) 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 completed HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the ongoing SYMMETRY study in patients with compensated cirrhosis (F4) due to MASH, in which a total of over 300 patients have been treated with EFX or placebo for up to 96 weeks. 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, including future plans or expectations for EFX; the therapeutic effects of EFX; the dosing, safety and tolerability of EFX; as well as expected timing for reporting results of ongoing clinical trials, including the SYNCHRONY Real-World study. 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
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com
Media Contact:
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Deerfield Group
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FAQ
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