SOUTH SAN FRANCISCO, Calif., Aug. 28, 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 Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, September 8, 2025, at 10:45 a.m. E.T. in New York, NY. A live webcast of the Company presentation will be available through the investor relation ...

Core Insights - The publication of the 96-week results from the Phase 2b HARMONY trial indicates the potential of efruxifermin (EFX) to significantly reduce the risk of fibrosis progression in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, which has a high unmet medical need [1][12] - Efruxifermin (EFX) is Akero's lead product candidate, currently being evaluated in three ongoing Phase 3 studies targeting different stages of MASH [9][12] Trial Results - The HARMONY trial was a 96-week multicenter, randomized, double-blind, placebo-controlled study involving 128 adult participants with biopsy-confirmed MASH and moderate to advanced fibrosis [2][11] - In the mITT population at week 96, 49% of participants receiving 50mg EFX achieved at least one stage of fibrosis improvement without worsening of MASH, compared to 19% for placebo (p=0.0030) [3][4] - Improvements in fibrosis were also noted in patients with more advanced disease, indicating EFX's potential effectiveness across different stages of MASH [3][4] Secondary Endpoints - The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX, compared to 19% for placebo [4] - A composite endpoint of both MASH resolution and at least one stage of fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX groups, respectively, versus 7% for placebo [4] Safety and Tolerability - EFX was generally well tolerated, with a safety profile consistent with previous trials; the most common adverse events were mild to moderate gastrointestinal issues [6] - A small reduction in bone mineral density was observed after 96 weeks of EFX treatment, although the clinical significance of this finding remains to be determined [6] Overall Impact - The sustained reductions in fibrosis and MASH observed in the trial reflect an overall improvement in whole-body metabolic health, including reduced dyslipidemia and increased insulin sensitivity [7] - The results from the HARMONY trial, along with data from the SYMMETRY trial, suggest that EFX has the potential to transform patient outcomes, particularly for those with a high fibrosis burden [3][7]

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]

Core Insights - The publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine highlights the potential benefits of efruxifermin (EFX) in improving fibrosis in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) after 96 weeks of treatment [1][3][4] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases, including MASH, with its lead product candidate being efruxifermin (EFX) [5][10] - The company is currently conducting three ongoing Phase 3 clinical studies related to EFX, building on the results of previous Phase 2b trials [5][10] Study Details - The SYMMETRY trial was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study involving 182 patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH [9] - The primary endpoint was defined as ≥1-stage fibrosis improvement without worsening of MASH at 36 weeks, with secondary outcomes assessed at 96 weeks [3][9] Efficacy Results - At 36 weeks, 19% of participants in the EFX 50mg group and 18% in the EFX 28mg group met the primary endpoint, compared to 13% for placebo [3] - At 96 weeks, 29% of participants in the EFX 50mg group and 21% in the EFX 28mg group showed fibrosis improvement without MASH worsening, compared to 11% in the placebo group [3] Safety and Tolerability - EFX was associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared to placebo [4] - The safety profile of EFX was consistent with previous trials, with observed adverse events primarily being mild to moderate gastrointestinal issues [4] Disease Context - MASH is estimated to affect 17 million Americans and is characterized by excessive fat accumulation in the liver, leading to inflammation and fibrosis [6] - Approximately 20% of patients with MASH may progress to cirrhosis, which poses a higher risk of mortality [6][8]

Core Insights - Akero Therapeutics presented promising results from the Phase 2b SYMMETRY trial for efruxifermin (EFX), indicating its potential to improve fibrosis in compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs, particularly MASH [12] - Efruxifermin (EFX) is Akero's lead product candidate, currently undergoing evaluation in three ongoing Phase 3 studies [11][12] Clinical Trial Results - The SYMMETRY trial involved 182 patients with biopsy-confirmed compensated cirrhosis (F4) due to MASH, with 181 patients receiving EFX or placebo for 96 weeks [10] - At Week 96, 39% of patients treated with EFX 50mg showed fibrosis improvement compared to 15% in the placebo group (p=0.009) [2][3] - In the intent-to-treat (ITT) analysis, 29% of patients in the EFX 50mg group experienced fibrosis improvement versus 11% for placebo (p=0.031) [2][3] Efficacy and Safety - EFX demonstrated a significant increase in treatment effect over time, with a placebo-adjusted treatment effect doubling from 10% at Week 36 to 24% at Week 96 [5] - Non-invasive measures of liver fibrosis and injury, such as ELF test scores and liver stiffness by Fibroscan, showed continued improvement for the EFX 50mg group over 96 weeks [6] - The safety profile of EFX was consistent with previous trials, with mild to moderate gastrointestinal adverse events being the most common [8] Future Directions - Akero plans to continue evaluating EFX across all stages of MASH in the Phase 3 SYNCHRONY program [2] - The company aims to address the complex, multi-system disease state of MASH, including improvements in cardiovascular risk factors linked to the condition [11]

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] Upcoming Events - Management will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 1:40 p.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] Clinical Development - Akero's 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 with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study and the SYMMETRY study [3]

Core Insights - Akero Therapeutics, Inc. is set to present significant findings related to its lead product candidate, efruxifermin (EFX), at the EASL Congress 2025, highlighting advancements in treating metabolic diseases with high unmet medical needs [1][3]. Presentation Details - The first oral presentation will focus on the results of a 96-week, randomized, double-blind, placebo-controlled Phase 2b trial (SYMMETRY) demonstrating that efruxifermin improves fibrosis in participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) [2]. - The second oral presentation will discuss the alignment of non-invasive fibrosis biomarkers and AI-based histology assessments in MASH clinical trials, providing a new roadmap for drug efficacy evaluation as demonstrated in the HARMONY trial [2]. - A poster presentation will showcase how qFibrosis enables earlier detection of fibrosis response in efruxifermin-treated patients with F2-F3 MASH in the 96-week HARMONY study [3]. Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, with efruxifermin being evaluated in three ongoing Phase 3 clinical studies [3]. - The Phase 3 SYNCHRONY program builds on the results from two Phase 2b trials, the HARMONY study and the SYMMETRY study, indicating a robust pipeline for addressing metabolic diseases [3].