Gyre Therapeutics Has Completed Patient Enrollment In The 52-week Phase 3 Trial In China Of Pirfenidone Capsules, For Pneumoconiosis

Author: Benzinga Newsdesk | October 15, 2025 06:05am

A total of 272 patients have been enrolled in this multicenter, randomized, double-blind, placebo-controlled trial being conducted at 18 clinical research centers across China. The trial is designed to evaluate the efficacy and safety of 52 weeks of Pirfenidone capsule treatment in patients with pneumoconiosis, a chronic occupational lung disease characterized by progressive pulmonary fibrosis.

Unmet Medical Need in Pneumoconiosis

Pneumoconiosis remains the most common and severe occupational disease in China, with more than 450,000 surviving patients and thousands of new cases reported each year. It results from long-term inhalation of mineral dusts such as silica or coal, which triggers persistent inflammation and progressive fibrosis of the lung tissue. Over time, this excessive scar formation causes diffuse fibrosis and irreversible loss of lung function. Despite its prevalence and severity, there is currently no approved therapy in China that specifically targets the fibrotic mechanisms underlying pneumoconiosis.

Based on recent expert consensus, China's pneumoconiosis treatment landscape represents a significant unmet medical need, underscoring the importance of developing therapies specifically designed to slow or halt the progression of fibrosis and improve long-term outcomes for affected patients.

About the 52-Week Phase 3 Trial

The ongoing trial compares Pirfenidone 1,800 mg/day (600 mg tid) with placebo over a 52-week double-blind treatment period.

• Primary Endpoint: Change from baseline in forced vital capacity (FVC) % predicted at Week 52.
• Key Secondary Endpoints: Changes in diffusing capacity of the lungs for carbon monoxide (DLCO), 6-minute walk distance, St. George's Respiratory Questionnaire (SGRQ) score, and Modified Medical Research Council (mMRC) dyspnea scale, as well as rates of acute exacerbations, hospitalizations, and deaths.
• Safety Monitoring: Follows Gyre's Development Safety Update Report (DSUR Dec 2023–Dec 2024). Most adverse events reported to date are mild to moderate, with no unexpected safety signals.
• Interim Analysis: None planned.

Posted In: GYRE