Innovent Biologics has announced that the first patient has been dosed in a Phase III clinical trial evaluating tigulixostat (IBI128), a next-generation xanthine oxidase inhibitor (XOI), for the treatment of gout.

The randomised, double-blind, multi-centre study will compare tigulixostat with febuxostat in approximately 600 patients in China diagnosed with gout under the 2015 ACR/EULAR criteria. Participants will be assigned in a 1:1 ratio to receive either tigulixostat 100 mg or febuxostat 40 mg over a 24-week treatment period, with the overall study duration extending to one year.

The primary endpoint is the proportion of patients achieving target serum uric acid levels below 360 μmol/L at Week 24, a key marker in effective gout management.

Tigulixostat previously demonstrated promising results in a Phase II study, showing superior urate-lowering efficacy and a favourable safety profile compared with febuxostat. These findings were presented at the Asia-Pacific League of Associations for Rheumatology conference.

Gout, a rapidly growing metabolic disorder in China, presents significant unmet medical needs due to limitations of existing treatments, including safety concerns such as cardiovascular risks, hypersensitivity reactions and challenges in patients with renal impairment.

Investigators highlighted that tigulixostat’s high selectivity and encouraging clinical profile could address these gaps. In earlier studies, the drug achieved high rates of uric acid control, with a notable proportion of patients reaching target levels within 16 weeks.

The Phase III trial is expected to provide robust, long-term data on efficacy and safety, potentially supporting the development of a new treatment option for gout patients.

Beyond tigulixostat, Innovent is advancing a broader pipeline in gout and hyperuricemia, including biologics and metabolic therapies targeting different stages of the disease. This strategy reflects the company’s focus on building a comprehensive portfolio to address the growing burden of metabolic disorders.

The initiation of the Phase III study marks a key milestone in Innovent’s efforts to expand treatment options and improve outcomes for patients with gout.