Innovent Announces Phase 2 Results of Tigulixostat (IBI128, XOI) in Gout Patients were Published at the 27th Asia-Pacific League of Associations for Rheumatology Congress

Core Viewpoint - Innovent Biologics announced positive results from the Phase 2 clinical study of tigulixostat, a xanthine oxidase inhibitor, showing superior urate-lowering efficacy compared to febuxostat in Chinese gout patients, leading to plans for a Phase 3 study in late 2025 [1][7][12]. Group 1: Clinical Study Results - The Phase 2 study involved 84 participants with a mean age of 37 years and a mean baseline serum uric acid level of 575 μmol/L (9.6 mg/dL) [3]. - At week 16, the proportion of participants achieving serum uric acid (sUA) levels below 360 μmol/L (6 mg/dL) was significantly higher in the tigulixostat groups: 55.0% for 50 mg, 81.0% for 100 mg, and 85.7% for 200 mg, compared to 18.2% for febuxostat [6]. - The percent change in sUA from baseline was -38.66% for the 50 mg group, -48.61% for the 100 mg group, and -57.11% for the 200 mg group, while febuxostat showed a change of -24.11% [6]. Group 2: Safety Profile - Tigulixostat exhibited a favorable safety profile with no increased risk of renal impairment and similar incidence of adverse events across groups, all of which were mild to moderate [6][12]. - No serious adverse events were reported, and the incidence of gout flare was comparable between tigulixostat and febuxostat groups [6]. Group 3: Market Context and Need - Gout and hyperuricemia are increasingly recognized as major chronic diseases, with a prevalence of hyperuricemia in China at 13.3%, affecting approximately 15.5 million gout patients [5]. - Current treatments like allopurinol and febuxostat have significant safety concerns, highlighting the urgent need for safer and more effective options [10][12]. Group 4: Future Development Plans - Based on the positive Phase 2 results, Innovent plans to accelerate the Phase 3 clinical development of tigulixostat to provide new treatment options for gout patients in China [7][12]. - The company is committed to advancing its pipeline in cardiovascular and metabolic diseases, addressing a broad population affected by related conditions [7].