Gyre Therapeutics, Inc. (Nasdaq: GYRE) has announced the completion of the last patient's 52-week treatment in its pivotal Phase 3 trial evaluating F351 (hydronidone) for Chronic Hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC). The company anticipates reporting topline data from this trial by the first quarter of 2025.
Han Ying, Ph.D., CEO of Gyre Therapeutics, expressed gratitude to the patients, researchers, and trial investigators, stating, “The final patient completing our pivotal F351 Phase 3 trial marks an important milestone for Gyre and our development pipeline... Furthermore, we are excited to potentially use these results to spur initiation of our Phase 2 clinical trial in the United States evaluating F351 for Metabolic Dysfunction-Associated Steatohepatitis (MASH)-associated fibrosis in 2025.”
Trial Design and Objectives
The Phase 3 trial (NCT05115942) was a randomized, double-blind, placebo-controlled, multicenter study conducted across 39 clinical research hospitals in the PRC. The trial enrolled 248 patients who were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB.
The primary endpoint of the trial is a decrease in liver fibrosis, measured by the Ishak Scoring System, by at least one stage after 52 weeks of treatment relative to baseline. F351 received Breakthrough Therapy designation from China’s National Medical Products Administration (NMPA) in 2021.
About Hydronidone (F351)
F351 is a structural analogue of pirfenidone, an approved anti-fibrotic drug used in the PRC for idiopathic pulmonary fibrosis. F351 has demonstrated the ability to inhibit p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (HSCs) in vitro. HSCs are recognized as critical in the development and progression of liver fibrosis. The anti-proliferative effects of F351 on HSCs have also been confirmed in several in vivo models of liver fibrosis, including CCI4-induced liver fibrosis in mice, DMN-induced liver fibrosis in rats, and HSA-induced liver fibrosis in rats, as well as a mouse model of MASH fibrosis (CCI4+Western High Fat Diet).
Gyre's Broader Pipeline
Gyre Therapeutics is focused on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. The company's strategy is based on mechanistic studies in MASH rodent models and clinical studies in CHB-induced liver fibrosis. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.
