Benzinga | Oct 19, 2021 04:15PM EDT

Akero Therapeutics Reports Received FDA Fast Track Designation For Efruxifermin For Treatment Of NASH

Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program investigating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH).

The Fast Track designation facilitates the development of new drugs to treat serious conditions where there is an unmet medical need. This designation enables more frequent interactions with the FDA and potential eligibility for priority review if clinical data support it. EFX is currently being evaluated in two parallel Phase 2b clinical trials in NASH patients, one (the HARMONY study) in adult patients with F2/F3 fibrosis and a second (the SYMMETRY study) in adult patients with late-stage cirrhotic NASH (F4), who are at elevated risk of liver failure and have the highest unmet medical need.

"The FDA Fast Track designation for EFX is an important step forward in potentially bringing EFX to the growing number of patients impacted by NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "Backed by positive clinical data, including a two-stage improvement in fibrosis for 50% of all treated patients with F2 or F3 fibrosis at baseline, we believe EFX has the potential to be among the first investigational therapies approved for treatment of both advanced fibrotic (F2/F3) and cirrhotic (F4) NASH. We look forward to working closely with the FDA to bring this promising investigational therapy to NASH patients as expediently as possible."

NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. An estimated 17 million Americans had NASH in 2016, a number that is expected to increase to 27 million by 2030. There are currently no approved therapies for NASH.

The FDA's decision to grant EFX Fast Track designation follows recent clinical milestones highlighting EFX's potential to address multiple drivers of NASH and reverse fibrosis. In July, Nature Medicine published full results of the main portion of Akero's Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis--the first published clinical evidence of fibrosis regression with an FGF21 analog. Additionally, earlier this year, Akero announced positive topline results from a 30-patient expansion cohort of the Phase 2a BALANCED study of EFX in late-stage (F4) cirrhotic NASH, which showed clinically meaningful improvements in fibrosis after 16 weeks of treatment.