NASH Drug Candidate, ASC42 Receives Fast Track Designation

A Non-Alcoholic Steatohepatitis (NASH) drug candidate ASC42, a Farnesoid X Receptor (FXR) Agonist from Gannex, received Fast Track designation from the U.S. Food and Drug Administration (FDA) on 14th December 2020.

The U.S. FDA’s Fast track is a process designed to facilitate new drug development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to the patient earlier. This Fast Track designation represents the FDA’s recognition of ASC42’s potential in addressing these unmet medical needs for NASH patients.

Regulatory History of ASC42

Gannex is a wholly-owned company of Ascletis Pharma Inc. and fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation, and fibrosis. The oral tablet formulation of ASC42 has been developed with in-house proprietary technology and is stable at room temperature.

NASH

NASH is a progressive liver disease caused by excessive accumulation of fat in the liver. It can cause chronic inflammation in the liver, trigger progressive liver fibrosis, cirrhosis, and ultimately lead to liver failure, cancer, and patient death. The liver-related mortality in patients with advanced fibrosis is significantly increased. However, there are no FDA approved medicines for NASH indication yet.

At present, NASH is predicted to be one of the largest drug markets in the field of drug treatment for liver diseases after hepatitis C. It is estimated that the global NASH therapeutic drug market will reach US$ 40 billion in 2025. In addition to Gannex’s ASC42, Potential drugs with rapid progress in clinical research include, e.g., GENFIT’s PPAR receptor agonist Elafibranor, Intercept’s farnesol receptor (FXR) agonist obeticholic acid (OCA), Allergan’s CCR2/CCR5 chemokine receptor blocker Cenicriviroc (CVC), Gilead’s anti-apoptotic signal-regulating kinase 1 (ASK1) inhibitor Selonsertib, and Inventiva’s pan-PPAR agonist Lanifibranor.

Related Article: Gilead and Novo Nordisk Present Proof-of-Concept Data for the First Possible NASH Treatment

Partner Article, By James Hou, Ph.D.

References

1. https://www.ascletis.com/news_detail/172/id/443.html

Author

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