New research accepted for publication by JHEP Report, a leading hepatology journal, shows the effectiveness of a drug developed by an Israeli company in combating severe fatty liver disease.
The paper summarizes years of research by Prof. Scott Friedman, chief of the Division of Liver Diseases at Mount Sinai Hospital’s Icahn School of Medicine in New York, together with Prof. Jose Mato of the Precision Medicine and Metabolism Laboratory at Spain’s CIC bioGUNE.
The researchers looked at the role of stearoyl CoA-Desaturase 1 (SCD1) in attenuating liver inflammation and damage caused by a buildup of fat, using the Israeli-developed oral therapy Aramchol.
The therapy, developed by Galmed, is in the midst of a Phase III clinical trial and has already been validated in animal models and in a large global Phase IIB study, where it was shown to downgrade fatty liver disease, liver inflammation and fibrosis, the thickening or scarring of the tissue.
The researchers found that Aramchol has a “direct antifibrotic effect” on the principal collagen-producing cell in the liver through its inhibition of SCD1.
“This exciting new data establishes a dual mechanism of action of Aramchol that reinforces its potential in NASH patients with fibrosis,” Friedman said. NASH stands for nonalcoholic steatohepatitis and means liver inflammation and damage that has been caused by a buildup of fat in the liver.
An estimated 3% to 5% of the US population and an estimated 2% to 4% of the global population suffers from NASH, according to Galmed co-founder Allen Baharaff. He said it is the fastest growing cause of liver cancer and reason for liver transplant in the US.
The news of the research comes at a time when fatty liver disease is at the forefront of conversation, in that it was recently determined that people with the disease are more likely to develop acute cases of COVID-19.
Research released earlier this month by Sheba Medical Center, Tel Hashomer, showed that mortality rates among patients with fatty liver disease were almost three times higher than those among COVID-19 patients who did not have the disease.
The Sheba study was conducted among 382 patients during the first coronavirus wave through May 2020. It found that 15.4% of the patients had chronic liver disease as an underlying medical condition. The mortality rate for them was 16.7% compared with 6.8% among COVID-19 patients without liver disease.
Baharaff said that whereas Israel is moving extremely fast with its vaccination campaign and most Israeli citizens are expected to be inoculated by the end of March, in other parts of the world, including the US, vaccination is moving slower. As such, he said, people with fatty liver disease should be considered a high-risk group and prioritized for inoculation.
Galmed is currently in the midst of the first part of a Phase III trial that is being conducted in 18 countries and across five continents. Baharaff said the data from the first part of that trial should be available by the end of 2021.
If the data continues to prove the efficacy of the treatment, a second 52-week trial will take place involving 1,000 patients and, based on that, the company will aim for Food and Drug Administration.
Baharaff said that he hopes to have Aramchol approved by the end of 2023.