Akero Therapeutics Initiates Phase 2b HARMONY Study of Efruxifermin (EFX) for the Treatment of NASH

SOUTH SAN FRANCISCO, CA, USA I February 24, 2021 I Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced it has screened the first patients for its Phase 2b HARMONY study evaluating efruxifermin (EFX), the company's lead product candidate for the treatment of NASH.

Akero launches Phase 2b study of EFX in NASH patients with F2/F3 fibrosis, moving forward potential foundational monotherapy

"The initiation of our Phase 2b HARMONY study is an important milestone that builds on strong data from our Phase 2a BALANCED study," said Andrew Cheng, M.D., Ph.D., President and CEO of Akero Therapeutics. "We previously showed that EFX has the potential to reverse fibrosis among treatment responders after just 16 weeks of treatment. The HARMONY study will evaluate fibrosis improvement among all study participants after 24 weeks of treatment. We continue to believe that EFX has the potential to be a foundational NASH monotherapy by directly reversing fibrosis and resolving the underlying disease drivers that lead to fibrosis, and by improving risk factors for cardiovascular disease, which remains the leading cause of mortality for NASH patients."

The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX or placebo. The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo during a long-term follow-up period to provide additional safety data.

The company expects to dose patients beginning early in the second quarter of this year and to report topline results in the second half of 2022.

About NASH
Non-alcoholic steatohepatitis (NASH) is a serious, life-threatening disease that has rapidly emerged as a leading cause of liver failure in the world and is the leading indication for liver transplant among women. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. NASH is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by hepatocyte injury, liver inflammation, and fibrosis that can progress to scarring (cirrhosis), liver failure, cancer and death. There are currently no approved therapies for the disease.

About Efruxifermin
Efruxifermin (EFX) is an 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. Previous clinical trials show that EFX has the potential to reverse fibrosis, resolve NASH, reduce liver fat, improve glycemic control, improve lipoprotein profile, and reduce body weight. EFX offers convenient once-weekly subcutaneous dosing.

About the Phase 2a BALANCED Study
The Phase 2a BALANCED study was a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed patients with NASH. The main study enrolled 80 patients for randomization to receive once-weekly subcutaneous dosing of 28, 50 or 70mg EFX or placebo. All three EFX dose groups met the primary endpoint and multiple secondary endpoints, including absolute reductions in liver fat of 12 to 14% as measured by MRI-PDFF at week 12, compared with 0.3% for placebo and relative reductions in liver fat of 63 to 72%, compared with 0% for placebo. Among treatment responders, defined as patients who achieved at least a 30% relative reduction in liver fat, 48% of all EFX patients achieved at least a one-stage improvement of fibrosis without worsening NASH after 16 weeks of treatment, compared with 0% for placebo. Among patients with baseline F2 or F3 fibrosis and end-of-treatment biopsy, 50% of EFX patients achieved at a 2-stage improvement in fibrosis while an additional 18% achieved a 1-stage improvement in fibrosis.

An expansion cohort (Cohort C) evaluated EFX for treatment of cirrhotic NASH patients (F4 fibrosis) and enrolled 30 patients randomized to receive once-weekly subcutaneous dosing of 50mg or placebo. Topline results of Cohort C, including the results of voluntary end-of-treatment biopsies, will be reported in the first half of this year.

About Akero Therapeutics
Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead program, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in Phase 2 clinical trials as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit us at www.akerotx.com for more information.

SOURCE: Akero Therapeutics

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