Akero Therapeutics Presents Analyses of Phase 2b HARMONY Study at the 2023 International Liver Congress Reinforcing and Characterizing EFX-Related Improvements in Liver Histopathology

Data show changes in non-invasive tests in EFX-treated patients were associated with improvements in NASH histopathology and highlight dose-dependent responses

SOUTH SAN FRANCISCO, Calif., June 23, 2023 (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, today announced two presentations of secondary and post-hoc analyses of the Phase 2b HARMONY study of efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). The posters are being presented at the 2023 International Liver Congress today and tomorrow and will be available on Akero’s website.

“We continue to be really pleased with the consistency of clinical response associated with EFX treatment across four independently conducted Phase 2 studies,” said Tim Rolph, chief scientific officer of Akero. “The new analyses not only expand on previously reported results, but also indicate non-invasive testing could be used to monitor clinical response to EFX in a real-world setting where liver biopsies are a barrier to diagnosis of NASH and assessment of treatment-related effects.”

“Noninvasive tests of liver injury, inflammation and fibrosis are improved by efruxifermin and correlate with histological improvements in patients with F2-F3 NASH: secondary analysis of Ph2b HARMONY study” (Poster TOP-091, Abstract 1669) was selected as a Top Poster (“among the best in its category”) and is being displayed in a dedicated area of the Congress.

• Results of non-invasive tests performed as part of the HARMONY study were correlated with EFX-related changes in liver histopathology after 24 weeks of treatment.
• The poster shows that EFX-associated changes in non-invasive tests were associated with improvements in NASH histopathology. Normalization of liver fat content and markers of liver injury, AST or ALT, was associated with higher probability of resolving histopathologic features of steatohepatitis and fibrosis after 24 weeks of treatment with EFX.
• These results indicate non-invasive tests could be used to monitor and predict responses to treatment with EFX among patients with F2-F3 fibrosis and NASH.
  

“Characterization of the Patterns of Resolution of Histopathology After Efruxifermin Treatment of Patients with NASH Fibrosis (F2/3) for 24 Weeks” (Poster FRI-512, Abstract #2440) was selected for presentation during the poster tour. It will be summarized by Akero’s vice president of clinical research and medical affairs, Reshma Shringarpure, between 15.30-16.15 CET as part of the Metabolism, Alcohol and Toxicity track hub on June 24th.

• The post-hoc semi-quantitative analysis characterized changes in liver histopathology through the evaluation of steatosis-activity-fibrosis (SAF) and SAF-Activity (SAF-A) scores.
• Improvements in SAF and SAF-A scores following treatment with EFX corroborated the already reported improvement in NASH-CRN fibrosis stage and substantial resolution of steatohepatitis.
• Post-hoc qualitative analyses investigated histological features associated with fibrosis regression by comparing post-treatment with pre-treatment biopsies.
• The comparison revealed intra-grade and intra-stage improvements which were not detected by categorical staging as a scoring system for histologic features of regression.
• These orthogonal post-hoc analyses provided evidence of a progressive dose-dependent response to EFX.
  

About NASH
NASH is a serious form of NAFLD (non-alcoholic fatty liver disease) that is estimated to affect 17 million Americans. NASH 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. There are no approved treatments for the condition and NASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.

About Efruxifermin
Efruxifermin (EFX), formerly known as AKR-001, is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2b HARMONY and SYMMETRY studies. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipids. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH 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 NASH, a disease without any approved therapies. Akero's lead product candidate, EFX, 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 is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis, compensated). EFX has also been evaluated in an expansion cohort of the SYMMETRY study, Cohort D, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH (F1-F3 fibrosis) and Type 2 diabetes, for which topline results were reported on June 5, 2023. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and Twitter 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, as well as the dosing, safety and tolerability of EFX, including in combination with GLP-1 therapies; and upcoming milestones, including the results, and expected timing to report such results of Akero’s Phase 2b SYMMETRY 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, including Cohort D, 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
212.362.1200
IR@akerotx.com

Media Contact:
Sarah O’Connell
732.456.0092
soconnell@vergescientific.com