Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Clinical Development - The lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations affected by MASH [3] - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials: the HARMONY study for pre-cirrhotic MASH and the SYMMETRY study for compensated cirrhosis due to MASH [3] Upcoming Events - Management will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 8:45 a.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2]

Core Insights - Akero Therapeutics announced results from the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) for patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][6] - The study demonstrated the antifibrotic activity of EFX, with over half of patients treated with 50mg EFX classified as responders by AI-based digital pathology and non-invasive tests, compared to fewer than 5% of placebo patients [2][3] Group 1: Study Details - The HARMONY study was a multicenter, randomized, double-blind, placebo-controlled trial involving 128 biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3 [6] - Patients received either 28 mg or 50 mg EFX or placebo for 24 weeks, with the study continuing for up to 96 weeks [6] - The primary efficacy endpoint was the proportion of subjects experiencing ≥1-stage fibrosis improvement without worsening of MASH [6] Group 2: Results and Analysis - AI-based qFibrosis® analysis showed that after 24 weeks, the antifibrotic effect of EFX was greater than conventional pathology, with 18 patients identified as responders compared to 10 by conventional methods [3] - At Week 96, consistency was observed between conventional pathology and qFibrosis®, with 77% and 81% of patients classified as responders, respectively [3] Group 3: Presentations and Speakers - An oral presentation titled "Alignment of response assessed by non-invasive fibrosis biomarkers and HistoIndex AI-based qFibrosis histology in metabolic dysfunction associated steatohepatitis (MASH) clinical trials" was given by Prof. Quentin M. Anstee [4] - A poster presentation titled "qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY study" was presented by Dr. Jörn M. Schattenberg [5] Group 4: About EFX - Efruxifermin (EFX) is Akero's lead product candidate for MASH, currently evaluated in three ongoing Phase 3 studies [7][8] - EFX has shown potential to reverse fibrosis, resolve MASH, and improve insulin sensitivity and lipoprotein profiles, addressing the complex disease state of MASH [7]

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 ...

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, presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin (EFX) to improve fibrosis in compensated cirrhosis (F4) caused by metabolic dysfunction-associated steatohepatitis (MASH), in a late-breaking oral presentation at the Eur ...

SOUTH SAN FRANCISCO, Calif., May 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 that management will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025, at 1:40 p.m. P.T. A live webcast of the Company presentation will be available through the investor relations section of the Company's website ...

SOUTH SAN FRANCISCO, Calif., April 30, 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 two oral presentations and an upcoming poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, 2025, in Amsterdam, the Netherlands. Details for the presentations are as follows: Oral p ...