Akero Therapeutics to Present Phase 2b HARMONY Results
SOUTH SAN FRANCISCO, Calif., Sept. 08, 2022 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with severe metabolic disease marked by need unsatisfied medical high, will hold an investor conference on Tuesday, September 13 at 8:00 a.m. ET to share results from its HARMONY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with pre-cirrhotic non-alcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3).
Conference Call/Webcast Details
The company will host a conference call and webcast with slide presentation at 8:00 a.m. ET on Tuesday, September 13. Please click here to register for the event. The live webcast will be available on the Events & Presentations page of Akero’s website, with the recording and presentation available immediately following the event.
NASH (non-alcoholic steatohepatitis) is a severe form of NAFLD (non-alcoholic fatty liver disease) estimated to affect 17 million Americans. NASH is characterized by excessive fat accumulation in the liver that causes stress and damage to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. There is no approved treatment for the disease, and NASH is one of the leading causes of liver transplants in the United States and Europe.
About the HARMONY Study
The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, dosing trial in biopsy-confirmed adult patients with pre-cirrhotic NASH, fibrosis stage 2 or 3. The study recruited a total of 128 patients, randomized to receive once a week a subcutaneous dose of 28 mg or 50 mg of EFX, or a placebo. The primary efficacy endpoint of the study is the proportion of subjects who achieve at least one stage improvement in fibrosis without worsening of NASH at week 24. Additional secondary measures at week 24 include other liver histology endpoints; non-invasive markers of liver fibrosis; change from baseline in liver fat, liver enzymes, glycemic control, lipoproteins and body weight as well as safety and tolerability measures. To provide long-term safety data, patients will continue treatment with EFX or placebo for a follow-up period of up to 96 weeks.
Efruxifermin (EFX) is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing HARMONY Phase 2b study. EFX is designed to reverse fibrosis, reduce liver fat and inflammation, increase insulin sensitivity, and improve lipoproteins. This holistic approach offers the potential to treat the complex, multi-system disease state of NASH, including improving lipoprotein risk factors for cardiovascular disease – the leading cause of death in NASH patients. Designed to mimic the biological activity profile of native FGF21, EFX offers 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 severe metabolic diseases marked by significant unmet medical need, including non-alcoholic steatohepatitis (NASH), a disease with no approved therapy. Akero’s lead product candidate, efruxifermin (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 attenuates cellular stress and regulates metabolism throughout the body. EFX is designed to provide convenient once-weekly subcutaneous dosing. The consistency and magnitude of the observed effects positions EFX as a potentially best-in-class drug, if approved, for the treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (fibrosis F2-F3) and the SYMMETRY study in patients with cirrhotic NASH (fibrosis F4, compensated). EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-NASH. – cirrhosis (fibrosis F1-F3) and type 2 diabetes. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and Twitter for more information.
Statements 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 plans or future expectations for efruxifermin (EFX), the therapeutic effects of EFX, as well as the dosage, safety and tolerability of EFX; and next steps, including results, and the expected timeline for reporting these results from Akero’s Phase 2b HARMONY study. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. Risks that contribute to the uncertain nature of forward-looking statements include: risks relating to the impact of COVID-19 on Akero’s current and future operations, including potential adverse impacts on Akero employees, third parties , manufacturers, supply chain and production as well as global economies and financial markets; the success, cost and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute its strategy; positive results from a clinical study are not necessarily 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 the risks and uncertainties discussed in more detail under “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 these statements to reflect events that occur or circumstances that exist after the date on which they were made.