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Akero Therapeutics to Present Preliminary Topline Week 96 Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis (F4) Due to MASH

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Akero Therapeutics (NASDAQ: AKRO) has announced an upcoming investor webcast scheduled for Monday, January 27, 2025, at 8:00 a.m. ET. The company will present preliminary topline week 96 results from its SYMMETRY Phase 2b study, which evaluates efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).

The study is designed as a double-blind, placebo-controlled trial. The presentation will include a webcast with slides, available on the Events & Presentations page of Akero's website, with recording and presentation materials to be made available immediately after the event.

Akero Therapeutics (NASDAQ: AKRO) ha annunciato un prossimo webcast per investitori programmato per lunedì 27 gennaio 2025, alle 8:00 a.m. ET. L'azienda presenterà i risultati preliminari alla settimana 96 dello studio SYMMETRY di fase 2b, che valuta l'efruxifermin (EFX) in pazienti con cirrosi compensata (F4) a causa della steatoepatite metabolica (MASH).

Lo studio è progettato come un trial controllato, in doppio cieco e con placebo. La presentazione includerà un webcast con diapositive, disponibile nella pagina Eventi e Presentazioni del sito web di Akero, con la registrazione e il materiale della presentazione che saranno resi disponibili immediatamente dopo l'evento.

Akero Therapeutics (NASDAQ: AKRO) ha anunciado un próximo webcast para inversores programado para el lunes 27 de enero de 2025, a las 8:00 a.m. ET. La compañía presentará los resultados preliminares de la semana 96 del estudio SYMMETRY de fase 2b, que evalúa el efruxifermin (EFX) en pacientes con cirrosis compensada (F4) debido a la esteatohepatitis asociada a disfunción metabólica (MASH).

El estudio está diseñado como un ensayo controlado con placebo y a doble ciego. La presentación incluirá un webcast con diapositivas, disponible en la página de Eventos y Presentaciones del sitio web de Akero, con la grabación y los materiales de presentación que estarán disponibles inmediatamente después del evento.

Akero Therapeutics (NASDAQ: AKRO)는 2025년 1월 27일 월요일 오전 8시(ET)에 예정된 투자자 웹캐스트를 발표했습니다. 이 회사는 대사 기능 장애와 관련된 지방간염(MASH)으로 인한 보상성 간경변(F4) 환자에서 efruxifermin (EFX)의 효능을 평가하는 SYMMETRY 2b 단계 연구의 96주 preliminari 결과를 발표할 것입니다.

이 연구는 이중 맹검, 위약 대조 시험으로 설계되었습니다. 발표에는 Akero 웹사이트의 이벤트 및 발표 페이지에서 제공되는 슬라이드와 함께하는 웹캐스트가 포함되며, 이벤트 직후에 기록 및 발표 자료가 제공될 예정입니다.

Akero Therapeutics (NASDAQ: AKRO) a annoncé une prochaine diffusion en direct pour les investisseurs prévue pour le lundi 27 janvier 2025, à 8h00 ET. L'entreprise présentera les résultats préliminaires de la semaine 96 de l'étude SYMMETRY de phase 2b, qui évalue l'efruxifermin (EFX) chez des patients atteints de cirrhose compensée (F4) devido à la stéatohépatite associée à une dysfonction métabolique (MASH).

Cette étude est conçue comme un essai contrôlé, en double aveugle. La présentation comprendra un webcast avec des diapositives, disponible sur la page Événements & Présentations du site Web d'Akero, et l'enregistrement ainsi que les documents de présentation seront disponibles immédiatement après l'événement.

Akero Therapeutics (NASDAQ: AKRO) hat ein bevorstehendes Investor-Webcast angekündigt, das für Montag, den 27. Januar 2025, um 8:00 Uhr ET geplant ist. Das Unternehmen wird die vorläufigen Ergebnisse der Woche 96 aus der SYMMETRY Phase 2b-Studie präsentieren, die efruxifermin (EFX) bei Patienten mit kompensierter Zirrhose (F4) aufgrund von stoffwechselbedingter Steatohepatitis (MASH) bewertet.

Die Studie ist als doppelblinde, placebo-kontrollierte Studie konzipiert. Die Präsentation wird ein Webcast mit Folien beinhalten, der auf der Seite Veranstaltungen & Präsentationen der Akero-Website verfügbar sein wird, und die Aufzeichnung sowie das Präsentationsmaterial werden unmittelbar nach der Veranstaltung zur Verfügung gestellt.

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Investor webcast on Monday, January 27, 2025, at 8:00 a.m. ET to present clinical data

SOUTH SAN FRANCISCO, Calif., Jan. 24, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Monday, January 27, 2025, at 8:00 a.m. ET to share preliminary topline week 96 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).

Conference Call / Webcast Details
The company will host a conference call and webcast with slide presentation at 8:00 a.m. ET on Monday, January 27. Please click here to register for the event. The live webcast will be available on the Events & Presentations page of the Akero website, with the recording and presentation available immediately following the event.

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 eventually 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 Study
The Phase 2b SYMMETRY study is a 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 enrolled a total of 182 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 36 weeks, 181 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of patients who achieve at least one-stage fibrosis improvement without worsening of MASH at week 36. Week 96 secondary measures included ≥1 stage fibrosis improvement and no worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, glycemic control, and lipoproteins, 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.

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, EFX, is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic MASH (F2-F3 fibrosis), SYNCHRONY Outcomes in patients with compensated cirrhosis 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. 

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, and ongoing clinical studies, 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
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com

Media Contact:
Peg Rusconi
Deerfield Group
617.910.6217
peg.rusconi@deerfieldgroup.com 


FAQ

When will Akero Therapeutics (AKRO) release the SYMMETRY Phase 2b study results?

Akero Therapeutics will release preliminary topline week 96 results from the SYMMETRY Phase 2b study on Monday, January 27, 2025, at 8:00 a.m. ET during an investor webcast.

What is the purpose of Akero's SYMMETRY Phase 2b study?

The SYMMETRY study evaluates the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).

How can investors access Akero's SYMMETRY study results presentation?

Investors can access the presentation through a live webcast on the Events & Presentations page of Akero's website, with recording and presentation materials available immediately following the event.

What type of clinical trial is the AKRO SYMMETRY study?

The SYMMETRY study is a double-blind, placebo-controlled Phase 2b clinical trial.

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