Gyre Therapeutics Announces Publication of Phase 3 Trial Protocol for Hydronidone in Liver Fibrosis Associated with Chronic Hepatitis B
SAN DIEGO, CA – March 27, 2025 – Gyre Therapeutics, a pioneering, commercial-stage biotechnology company specializing in organ fibrosis, made a significant announcement yesterday concerning the publication of a manuscript in the Journal of Clinical and Translational Hepatology. This manuscript, titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial,” provides a comprehensive look into Gyre’s pivotal Phase 3 trial for the use of hydronidone in treating liver fibrosis in Chinese patients with chronic hepatitis B (CHB).
Background
Liver fibrosis, a condition characterized by scarring of the liver, can lead to serious health complications, including liver cirrhosis and even liver cancer. Chronic hepatitis B (CHB) is a major cause of liver fibrosis worldwide, particularly in Asia. Currently, there are limited treatment options for CHB-associated liver fibrosis, making the development of effective therapies a critical area of research.
The Gyre Therapeutics Solution: Hydronidone
Hydronidone is a small molecule inhibitor of the TGF-β1 signaling pathway, a key driver of liver fibrosis. Gyre has previously reported positive results from Phase 2 trials of hydronidone in the treatment of CHB-associated liver fibrosis in Chinese patients. The upcoming Phase 3 trial, as outlined in the published manuscript, aims to further validate the safety and efficacy of hydronidone in a larger patient population.
Details of the Phase 3 Trial
The Phase 3 trial is a randomized, double-blind, placebo-controlled study involving approximately 500 patients with CHB-associated liver fibrosis. Patients will be randomly assigned to receive either hydronidone or a placebo for 52 weeks. The primary endpoint of the study is the change in liver fibrosis stage as assessed by a liver biopsy at week 52. Secondary endpoints include changes in liver enzymes, quality of life, and safety.
Implications for Patients and the World
For Patients:
- If successful, hydronidone could provide a much-needed treatment option for CHB patients suffering from liver fibrosis.
- The trial results could lead to improved quality of life and potentially prevent progression to more severe liver diseases, such as cirrhosis and liver cancer.
For the World:
- The successful development of hydronidone for CHB-associated liver fibrosis could set a precedent for the treatment of other fibrotic diseases, such as idiopathic pulmonary fibrosis and systemic sclerosis.
- Given the high prevalence of CHB and liver fibrosis in Asia, a successful trial could have a significant impact on public health in that region.
Conclusion
Gyre Therapeutics’ publication of the Phase 3 trial protocol for hydronidone in the treatment of CHB-associated liver fibrosis is an important step forward in the development of this potential life-changing therapy. With positive results from previous trials and a well-designed Phase 3 study, Gyre is poised to make a significant impact on the lives of millions of CHB patients worldwide. As the trial progresses, we will continue to monitor the developments closely and report on any updates.
Stay tuned for more updates on this exciting area of research!
