(Reuters) – Akero Therapeutics Inc said on Monday data from a mid-stage study showed its experimental therapy reduced liver fat by 65% in certain patients with a type of fatty liver disease called nonalcoholic steatohepatitis (NASH).
The drug, efruxifermin, also met secondary efficacy goals when tested alongside a diabetes treatment belonging to a class of drugs known as GLP-1 receptor agonists in the trial.
Efruxifermin is being tested as a potential therapy for patients with diabetes due to NASH, who are already being treated with the diabetes drug, to see if the combined drugs have an added benefit.
The side-effect profile of its experimental drug was similar to that seen in previous studies, Akero said. Most of the patients with NASH suffer with type 2 diabetes, it added.
NASH has no approved treatments and the disease is the fastest-growing cause of liver transplants in developed countries.
In the trial, 88% of patients’ absolute liver fat level normalized to 5% or less when treated with Akero’s drug and a GLP-1 therapy, compared to 10% treated with a GLP-1, Akero said in a statement.
The patients treated with efruxifermin also showed statistically significant improvements in liver enzymes and non-invasive markers of liver scarring, levels of blood sugar.
Several drugmakers including Novo Nordisk, Madrigal Pharmaceuticals Inc and Intercept Pharmaceuticals are racing to enter what is expected to be a multibillion dollar U.S. market.
Last month, U.S. Food and Drug Administration’s reviewers flagged increased risk of diabetes and liver injury from using the Intercept Pharma’s oral tablets for the disease.
Akero plans to commence two late-stage studies of the therapy later this year.
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