Gyre Therapeutics Publishes in Gastroenterology and Hepatology Journal

Gyre Therapeutics, a biotechnology company listed on Nasdaq under the symbol GYRE, has recently announced a significant development in the treatment of liver fibrosis. The company has published a manuscript in the Journal of Gastroenterology and Hepatology, highlighting the promising potential of hydronidone (F351) in combating liver fibrosis. This new treatment, derived from pirfenidone, has shown encouraging results in both animal and cellular studies.

The manuscript, titled "Hydronidone induces apoptosis in activated hepatic stellate cells through endoplasmic reticulum stress-associated mitochondrial apoptotic pathway," details the mechanisms through which hydronidone works. According to Han Ying, Ph.D., CEO of Gyre, the drug has demonstrated the ability to mitigate liver fibrosis by inducing apoptosis in activated hepatic stellate cells (aHSCs) through the endoplasmic reticulum stress (ERS)-associated mitochondrial apoptotic pathway. Ying added that these findings significantly enhance the understanding of hydronidone and underscore its potential as a therapeutic option for liver fibrosis.

Liver fibrosis is a condition marked by the excessive buildup of extracellular matrix (ECM), leading to disrupted liver architecture. Activated hepatic stellate cells (HSCs) are central to this process, transforming into myofibroblast-like cells that produce ECM in chronic liver disease. Research indicates that reversing liver fibrosis may be possible by eliminating these aHSCs. The study revealed that hydronidone effectively promotes apoptosis in aHSCs in both CCl4- and DDC-induced liver fibrosis in mice and LX-2 cells. Mechanistic studies have further shown that hydronidone triggers ERS, activates the IRE1α-ASK1-JNK pathway, and causes mitochondrial dysfunction, resulting in aHSC apoptosis.

Gyre's subsidiary, Gyre Pharmaceuticals in China, is currently conducting a Phase 3 clinical trial to evaluate hydronidone for treating Chronic Hepatitis B (CHB)-associated liver fibrosis. This trial, involving 248 patients, aims to reduce the liver fibrosis score by at least one grade after administering hydronidone in combination with entecavir. Topline data from this trial is expected by early 2025. Depending on these results, Gyre plans to initiate a Phase 2a proof-of-concept trial in 2025 to evaluate hydronidone for treating NASH-associated liver fibrosis.

Gyre Therapeutics, headquartered in San Diego, CA, focuses on developing and commercializing F351 (Hydronidone) for treating NASH-associated fibrosis in the United States. The company's strategy for F351's development in NASH leverages its experience from NASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical trials. Additionally, through its subsidiary Gyre Pharmaceuticals, the company is advancing a diverse pipeline in China, including therapeutic expansions such as ETUARY, F573, F528, and F230.

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