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Patients treated with efruxifermin (AKR-001) showed improvements in markers of insulin sensitivity and lipoprotein metabolism; sustained exposure over time.

SOUTH SAN FRANCISCO, Calif.July 21, 2020  Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic, non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance, today announced the publication of data in the journal Cell Reports Medicine from the Phase 1 clinical trial of efruxifermin (EFX, formerly AKR-001), a fibroblast growth factor 21 (FGF21) analog, demonstrating its potential to modulate biomarkers associated with metabolic diseases, including NASH.

In the article entitled, “AKR-001, an Fc-FGF21 analog, showed sustained pharmacodynamic effects on insulin sensitivity and lipid metabolism in type 2 diabetes patients,” researchers found that EFX demonstrated a sufficiently prolonged half-life of 3-3.5 days to support weekly dosing. In addition, with a variation in systemic concentration of only 2-fold when dosed weekly, treatment with EFX delivered larger and more consistent improvements in markers of insulin sensitivity and lipid metabolism than previously reported for FGF21 analogs, and it was reported to be generally well tolerated. Weekly administration of 70mg demonstrated larger metabolic effects than dosing every other week with 140mg, even though exposure to EFX was comparable.

“Efruxifermin is the first FGF21 analog to demonstrate a pharmacokinetic profile that would enable sustained, balanced agonism across all of FGF21’s receptors with once weekly dosing,” said Tim Rolph, D.Phil., chief scientific officer and co-founder of Akero, and senior author of the manuscript.

Andrew Cheng, M.D., Ph.D., president and CEO of Akero, added, “The data reported in this study provided the rationale for evaluating the efficacy and safety of EFX in NASH patients in our Phase 2a BALANCED study, which met all endpoints. Our recent readouts of liver fat reductions and improvements in histological measures showed the largest reductions in liver fat and improvements in liver histology reported to date and confirm the promising clinical profile of EFX.”

In patients dosed weekly with 70mg EFX in the Phase 1 study, treatment was associated with an increase in insulin sensitivity as demonstrated by reductions in HOMA-IR. This enhancement of insulin sensivity by EFX was replicated in NASH subjects and associated with better glycemic control, as recently disclosed for the BALANCED study. Treatment with EFX in the Phase 1 study was associated with amelioration of dyslipidemia, prevalent among type 2 diabetes and NASH patients, who are susceptible to cardiovascular disease. An improved lipoprotein profile was also evident with EFX treatment in the BALANCED study.

About NASH
NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. 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. NASH is a leading cause of liver transplants in the US and Europe.

About Efruxifermin
Efruxifermin (EFX), formerly known as AKR-001, is Akero’s lead product candidate for NASH, engineered to mimic the biological activity of native FGF21. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. 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. EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

About Akero Therapeutics
Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company’s lead product candidate, efruxifermin (formerly AKR-001), has been evaluated in 80 patients with F1-F3 fibrosis in the main portion of the BALANCED study, and Akero is currently conducting cohort C of the study in non-decompensated F4 NASH patients.  Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.