Study Data Shows NASH Drug Targets Steatosis, Inflammation and Fibrosis

Study Data Shows NASH Drug Targets Steatosis, Inflammation and Fibrosis

Nonalcoholic steatohepatitis (NASH) has emerged as a global health crisis that is greatly undertreated and is also frequently undetected. NASH is considered to be the fastest growing cause of liver cancer and of liver transplants in the United States. The rising rate of obesity is the main cause of NASH, and the non-alcoholic fatty liver disease can also lead to cardiovascular disease, cirrhosis and liver-related mortality.

NASH has been widely undertreated, and there simply aren’t enough healthy livers that can be used as a match to treat the millions of people who may ultimately need liver transplants. There are estimates projecting that 3% to 5% of the U.S. population have NASH, and there are additional estimates that 2% to 4% of the world population could have NASH. 

An Israel-based company called Galmed Pharmaceuticals Ltd. is targeting liver, metabolic and inflammatory diseases. The company has announced an upcoming publication of a paper entitled “Aramchol Downregulates Stearoyl CoA-Desaturase 1 (SCD1) in Hepatic Stellate Cells to Attenuate Cellular Fibrogenesis” is coming out in the JHEP Reports and will be with a publish date on January 28, 2021. 

The paper summarizes a longstanding research collaboration and it describes the role of SCD1 in hepatic fibrogenesis for the first time, and it outlines the mechanism by which Aramchol exerts its anti-fibrotic effect directly by down regulation of SCD1 in hepatic stellate cells. According to Galmed’s press release, data further support Aramchol’s role in fibrosis reversal. This includes potential antifibrotic activity an ongoing Phase 3 study in patients with NASH and fibrosis.

Aramchol is a novel fatty acid bile acid conjugate, liver targeted SCD1 modulator, which is being developed as an oral therapy to treatment NASH and fibrosis. According to Galmed, its ability to modulate hepatic lipid metabolism was discovered and validated in animal models and demonstrated downregulation of the three key pathologies of NASH — steatosis, inflammation and fibrosis. 

Aramchol has already been granted Fast Track Designation status by the FDA for the treatment of NASH. A prior report from Galmed in December of 2020 indicated that the company was planning to meet with the FDA during the second-quarter of 2021 to discuss the introduction of Aramchol meglumine into the randomized, double-blind, placebo-controlled part of ARMOR by the fourth-quarter of 2021. 

Also in December of 2020 it was reported that all currently enrolled patients in both study arms will be given the opportunity to transition to an active regimen of Aramchol. Galmed had also reported that the 150 patients were expected to be comprised of both current ARMOR patients as well as new patients. 

An FDA Fast Track designation is not an automatic approval and there are still many months before the study data for efficacy and safety are known.  

For some additional data, the National Institute of Diabetes and Digestive and Kidney Diseases within the U.S. Department of Health and Human Services notes that NASH is a form of Nonalcoholic fatty liver disease (NAFLD) where the person has hepatitis—inflammation of the liver—and liver cell damage along with the fat in their liver. The group also notes that inflammation and liver cell damage can cause fibrosis, or scarring, of the liver. Its own statistics project that 30% to 40% of adults in the U.S. have NAFLD, with 3% to as 12% of adults having NASH.

Other companies are in various stages of NASH treatment and development as well. Some of those companies include the following: Gilead Sciences, Inc.; Bristol Myers Squibb; Abbvie (Allergan); Intercept Pharmaceuticals, Inc.; and Genfit SA. Estimates differ wildly about just how big this class of drugs may get in the coming decade, but treating the millions should likely result in billions of dollars being spent on the class of drugs. One published report from Research and Markets in July of 2020 projected that the global NASH drugs market is expected to be more than $84 billion by 2029.

About The Author

Kendra Evans

Kendra Evans founded Inflammation Guide in April 2020. Our goal is keeping our readers informed to help them live an empowered and full life while they manage inflammation. Inflammation Guide provides a central location for breaking news and updates on prescriptions, treatments, supplements and alternative wellness solutions to give options to people living with at least one inflammatory condition.

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