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Innovent Biologics (HKEX: 01801), a Chinese biopharmaceutical firm with a focus on oncology, autoimmune disorders, cardiovascular and metabolic diseases, and ophthalmology, presented promising Phase 2 clinical trial results for its xanthine oxidase inhibitor (XOI), tigulixostat (IBI128), at the 2025 Asia-Pacific League of Associations for Rheumatology (APLAR) Congress. The data suggests that tigulixostat could offer a more effective and safer alternative to existing treatments for gout, a market currently dominated by drugs with known limitations.
The randomized, open-label, multicenter, active-controlled Phase 2 study (NCT06501534) assessed the efficacy and safety of varying doses of tigulixostat in Chinese patients with gout. A total of 84 participants were enrolled with a mean age of 37 years, an average baseline serum uric acid (sUA) level of 9.6 mg/dL, and a mean baseline weight of 80.7 kg. Participants were split into four groups, receiving either tigulixostat at 50mg, 100mg or 200mg, or febuxostat at 40mg over a 16 or 18 week period. The primary goal was to see what proportion of participants achieved an sUA level of less than 6.0 mg/dL.
The results published at APLAR showed tigulixostat demonstrating a significantly greater urate-lowering effect compared to febuxostat across all dose groups, indicating a dose-dependent correlation. At week 16, the rates of participants achieving the target sUA level were 55.0%, 81.0%, and 85.7% in the 50mg, 100mg, and 200mg tigulixostat groups, respectively, compared to only 18.2% in the febuxostat group (p less than 0.05, less than 0.01, and less than 0.001, respectively). The percent change in sUA from baseline were -38.66%, -48.61%, -57.11% in the tigulixostat 50mg, 100mg, or 200mg groups compared to -24.11% in the febuxostat 40mg group. The robust response rates could position the drug favorably in a market keen for enhanced efficacy.
Beyond efficacy, safety is a key differentiating factor. Tigulixostat’s safety profile was described as favorable, with no increased risk of renal impairment observed during the study. The overall incidence of adverse events was similar across all treatment groups and graded mild to moderate in nature. Importantly, there were no serious adverse events reported in any of the tigulixostat groups, nor were there any adverse events leading to the discontinuation of the study drug. This is critical considering concerns surrounding the cardiovascular safety of febuxostat, a black box warning on the drug’s label which has hampered its usage, and the hypersensitivity issues with allopurinol, especially among Han Chinese populations.
Professor Hejian Zou from Huashan Hospital affiliated with Fudan University and the study’s principal investigator, highlighted the growing prevalence of gout and hyperuricemia in China, classifying it as a “fourth major” chronic disease after hypertension, hyperlipidemia, and hyperglycemia. “Currently, commonly used clinical drugs for gout in China face safety concerns, including potential cardiovascular risks and hepatorenal toxicity, highlighting the urgent need for safer and more effective treatment options,” Professor Zou stated. This underscores the potential market opportunity for tigulixostat should it prove to be both safe and effective through pivotal trials.
Innovent’s Chief R&D Officer of General Biomedicine, Dr. Lei Qian, commented on the company’s plans to accelerate the Phase 3 clinical development of tigulixostat. “Building on these findings and through ongoing communication with regulatory authorities, we will accelerate the Phase 3 clinical development of tigulixostat to bring this promising treatment option to Chinese gout patients as soon as possible,” Dr. Qian noted.
Based on these Phase 2 results, Innovent plans to initiate a Phase 3 clinical study of tigulixostat in China in the second half of 2025. This is a significant step toward potentially addressing a substantial unmet medical need within the Chinese market and may pose a material challenge to other gout treatments currently available. Analysts will be closely watching the Phase 3 results, the regulatory pathway and potential market penetration of tigulixostat as Innovent continues to build its portfolio of treatments for chronic illnesses.
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