Core Viewpoint - Gyre Therapeutics has published promising research on hydronidone, a novel derivative of pirfenidone, indicating its potential as a therapy for liver fibrosis through the induction of apoptosis in activated hepatic stellate cells [1][5]. Company Overview - Gyre Therapeutics is a clinical-stage biotechnology company focused on developing anti-fibrotic therapeutics for chronic organ diseases, particularly liver fibrosis [1][3]. - The company is headquartered in San Diego, CA, and is advancing a diverse pipeline, including F351 (Hydronidone) and other therapeutic candidates [3]. Research Findings - The study published in the Journal of Gastroenterology and Hepatology demonstrated that hydronidone significantly promotes apoptosis in activated hepatic stellate cells (aHSCs) in both in vivo and in vitro models [2][5]. - Mechanistic studies revealed that hydronidone triggers endoplasmic reticulum stress (ERS) and activates the IRE1α-ASK1-JNK pathway, leading to mitochondrial dysfunction and apoptosis of aHSCs [2][5]. Clinical Development - Gyre is currently evaluating hydronidone in a Phase 3 trial for Chronic Hepatitis B (CHB)-associated liver fibrosis in the People's Republic of China, with topline data expected by early 2025 [6]. - The trial involves 248 patients and aims to reduce the liver fibrosis score by at least one grade after treatment with hydronidone in combination with entecavir [6]. - Following the Phase 3 trial, Gyre plans to initiate a Phase 2a proof-of-concept trial for NASH-associated liver fibrosis in 2025 [6].
Gyre Therapeutics Announces Publication in Journal of Gastroenterology and Hepatology