Akero Therapeutics, Inc. issued the following announcement on September 24.
Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that written guidance from the U.S. Food and Drug Administration (FDA) enables the company to implement an innovative combined Phase 2b/3 study design for pivotal efruxifermin (EFX) trials in NASH patients.
Under the planned adaptive trial design, Akero will evaluate two EFX doses in a 24-week Phase 2b portion of the trial to inform selection of a single dose for evaluation in the Phase 3 portion of the study. The company remains on track to initiate a Phase 2b/3 trial of EFX in biopsy-confirmed NASH patients in the first half of 2021.
"We are pleased that the FDA found our overall proposed adaptive Phase 2b/3 development program to be acceptable, and we are grateful for the additional clarity the agency provided as we finalize our study protocol," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We believe that the positive histological data in biopsy-confirmed NASH patients obtained from the BALANCED study provided the foundation necessary to align on an adaptive Phase 2b/3 trial design. Further analysis of data from the BALANCED study has strengthened our confidence in EFX's potential to be a foundational monotherapy in NASH."
The company will present the results of additional analyses from the BALANCED study at an upcoming scientific meeting.
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. As a result, NASH has become a leading cause of liver transplants in the US and Europe.
About Efruxifermin
Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX is designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-organ/tissue pathogenesis 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 human FGF21, EFX offers convenient once-weekly dosing.
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 and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.
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