Gyre Therapeutics (Nasdaq: GYRE) has announced the completion of the 52-week study for the final patient in its pivotal Phase 3 trial of F351 (Hydronidone) for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis in the People's Republic of China (PRC). The company anticipates topline results from this trial in the first quarter of 2025. Additionally, Gyre is preparing for the commercial launch of avatrombopag maleate tablets and nintedanib in the PRC, and plans to initiate a Phase 2 trial of F351 in MASH-associated liver fibrosis in the U.S. in 2025.
F351 Phase 3 Trial Completion
The Phase 3 trial evaluated 248 patients with CHB-associated liver fibrosis. The primary endpoint is the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after 52 weeks of treatment with F351 in combination with Entecavir. Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics, expressed optimism about F351's potential as a novel treatment for fibrotic disease.
Commercial Launches in China
Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the PRC, received approval from China’s National Medical Products Administration (NMPA) for avatrombopag maleate tablets in June 2024. This drug is indicated for the treatment of thrombocytopenia associated with chronic liver disease (CLD) in adult patients undergoing elective diagnostic procedures or therapy. The commercial launch is expected in the first half of 2025.
Nintedanib, a small-molecule drug for the treatment of idiopathic pulmonary fibrosis (IPF), acquired from Jiangsu Wangao Pharmaceuticals Co., Ltd., is also slated for commercialization in the PRC in 2025. Nintedanib is already approved globally for IPF treatment.
Planned Phase 2 Trial in the U.S.
Pending the results from the Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept clinical trial to evaluate F351 for the treatment of MASH-associated liver fibrosis in the U.S. in 2025.
Other Clinical Development Programs
Gyre Pharmaceuticals is also conducting a Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for injection, in the treatment of acute/acute-on-chronic liver failure.
Preclinical Development
F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (PAH), received NMPA approval for its Investigational New Drug (IND) application in May 2024, with a Phase 1 trial expected to begin in 2025. F528, a novel anti-inflammation agent targeting multiple inflammatory cytokines, is being evaluated in preclinical studies as a potential therapy for chronic obstructive pulmonary disease (COPD).
Financial Position
As of September 30, 2024, Gyre had cash and cash equivalents of $15.9 million, which the company anticipates will fund operations for at least 12 months following the issuance of the condensed financial statements.
For the quarter ended September 30, 2024, Gyre reported revenues of $25.5 million, compared to $32.0 million for the same period in 2023. The decrease was primarily due to lower anti-fibrosis drug sales. Net income for the quarter was $2.9 million, compared to $7.5 million in the same period in 2023.
