Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine.
The manuscript, available at this link, provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with Akero’s investigational drug, efruxifermin (EFX), an FGF21 analog, achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis after only 16 weeks treatment. Numerous endpoints are reported for the first time in Nature Medicine.
“This disclosure of EFX data in Nature Medicine marks the first published clinical evidence of fibrosis regression with an FGF21 analog and what we believe are the largest reductions in liver fat publicly reported to date across all NASH investigational drug classes,” said Kitty Yale, chief development officer of Akero. “We’re pleased to contribute to the field of NASH clinical research with publication of these data. We extend gratitude to the trial participants who made this study possible.”
NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. There are currently no approved therapies for NASH. Weight loss of 10 percent or more has been shown to reverse NASH by restoring normal levels of liver fat and reducing insulin resistance. Unfortunately, achieving this degree of weight loss through lifestyle change is very challenging.
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