Positive findings for resmetirom and icosabutate were presented at the meeting in June.
Leading hepatology researchers unveiled new developments in the treatment of nonalcoholic fatty liver disease (NAFLD) at the International Liver Congress 2021 meeting in Geneva, Switzerland, during late June.
Linked to growing rates of obesity and diabetes, NAFLD has emerged as the most important cause of chronic liver disease worldwide and occurs in about a quarter of the global population, the European Association for the Study of the Liver (EASL), the organizer of meeting, said in a media statement. Experts predict that over the next decade, the condition will become the leading cause of end-stage liver disease and liver transplantation, according to the statement.
“We are clearly in a race against time to develop new drugs and treatment for NAFLD before the epidemic worsens,” said Philip Newsome, general secretary of EASL and professor of experimental hepatology and director of the Centre for Liver Research at the University of Birmingham in the United Kingdom.
One of the major developments discussed at meeting was a study showing that noninvasively identified nonalcoholic steatohepatitis (NASH) patients treated with 100 mg per day of resmetirom for up to 52 weeks demonstrated rapid and sustained reduction in hepatic fat, fibrosis stage, LDL and atherogenic lipids, liver enzymes and inflammatory biomarkers. NASH is a form NAFLD characterized by inflammation in the liver as well as a build-up of fat.
Madrigal Pharmaceuticals, a biotech company in suburban Philadelphia, is developing resmetirom, a drug designed to increase the metabolism of fat in the liver. The company is conducting two phase 3 trial of the drug, MAESTRO-NASH and MAESTRO-NAFLD-1. A press release issued by the company said that the target enrollment of 900 patients with biopsy-proven NASH had been reached and that it expects to report topline results in the third quarter of 2022.
The results reported at the International Liver Congress meeting supported the use of noninvasive tests to monitor individual NASH patient response to resmetirom treatment, said Stephen Harrison, visiting professor of hepatology at the University of Oxford in the United Kingdom.
“News that resmetirom appears to make inroads against NASH is most welcome. We are hopefully beginning to draw a line in the sand on the treatment of fatty liver disease,” Newsome said.
Researchers also reported positive findings for icosabutate at the International Liver Congress meeting. Icosabutate is an oral, engineered eicosapentaenoic acid derivative with anti-inflammatory and antifibrotic effects.
Results from an ongoing 52-week, phase 2b study of icosabutate showed dose-dependent effects on several liver disease biomarkers, according to the press release. Arun Sanyal with Virginia Commonwealth University noted that treatment of NASH patients with icosabutate for 16 weeks had a dose-dependent improvement in multiple relevant biologic pathways, with broad and potent effects on markers of liver injury, inflammation and fibrogenesis along with improvements in glycemic control and atherogenic lipids.
"Sanyal concluded that these data, combined with a favorable safety profile to date, support a potential for impacting liver histology at 52 weeks as well as improving common comorbid conditions seen in NASH patients,” said a press release from the organizers of the International Liver Congress meeting.