HQ Team
March 4, 2024: US-based Akero Therapeutics, Inc., announced its mid-trial of a drug to treat fatty liver disease met its primary goals of efficacy and safety in patients, according to a company statement.
Pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), is a serious form of metabolic-associated steatotic liver disease that is estimated to affect more than 17 million Americans.
MASH is characterised 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.
There are no approved treatments for the condition and MASH is the fastest-growing cause of liver transplants and liver cancer in the United States and Europe.
Metabolic dysfunction-associated steatotic liver disease is a type of steatosis that’s caused by factors other than excessive alcohol use.
Obesity, diabetes
The exact cause isn’t completely understood, but it often occurs with other metabolic disorders such as high cholesterol, obesity and diabetes.
Akero Therapeutics drug efruxifermin (EFX) after 24 weeks of treatment had met its primary goal of improvement in fibrosis with no worsening of MASH. The dosage group consisted of both 50mg and 28mg. Both the groups reported improvement of 75% and 46% respectively, compared to about 24% in the placebo group.
The study also met an additional histology endpoint at week 96 — notably 36% and 31% of patients treated with 50mg and 28mg experienced a two-stage improvement in fibrosis without worsening of MASH. That was more than 10-fold the placebo rate of 3%, according to the statement.
“The statistically significant results for first and second-stage (trials) fibrosis improvement and no worsening of MASH observed for 50mg EFX at week 96 are the largest response rates reported publicly to date for these endpoints in any MASH population,” said Stephen Harrison, MD, medical director of Pinnacle Clinical Research and the study’s principal investigator.
Phase-III trials
Results of the phase 2 studies, which involve a second biopsy after 96 weeks of treatment, “remain on track to be reported in the first quarter of 2025,” according to the statement.
A third clinical trial in patients with cirrhosis due to MASH is expected to be initiated in the first half of 2024.
“We believe the statistically significant 2-stage improvement in fibrosis without worsening of MASH observed in approximately one in three EFX-treated patients sets EFX apart,” said Andrew Cheng, MD, PhD, president and chief executive officer of Akero.
“Today’s results show that longer exposure to EFX has the potential to yield sustained fibrosis improvement as well as widening anti-fibrotic treatment responses across the treated patient populations.
“We look forward to continuing our evaluation of EFX in patients with pre-cirrhotic MASH and cirrhosis due to MASH in our ongoing Phase 3 program, in which two out of three studies are actively enrolling,” he said.
