China-based Innovent Biologics (HKG: 1801) has announced a strategic collaboration and license agreement with South Korea firm LG Chem Life Sciences, obtaining exclusive development and commercialization rights to the latter’s tigulixostat in China. Innovent Bio will pay LG Chem a USD 10 million upfront payment and is committed to USD 85.5 million in milestone payments, alongside annual net sales-based royalties.
Tigulixostat: A Promising Treatment for Hyperuricemia
Tigulixostat is a late-stage novel non-purine xanthine oxidase inhibitor for the management of chronic hyperuricemia in patients with gout. The molecule inhibits the activity of xanthine oxidase to prevent hypoxanthine and xanthine from metabolizing into uric acid, thereby reducing the production of uric acid.
Unmet Medical Need and Market Potential
Hyperuricemia is one of the most prevalent chronic diseases globally, with a significant patient population. The prevalence rate of hyperuricemia is as high as 13.3% in China. Moreover, hyperuricemia is a predisposing condition for gout, and the number of hyperuricemia patients with gout symptoms is up to 15.5 million in China. Current therapies, such as febuxostat and allopurinol, have limitations: febuxostat has potential cardiovascular risks, and allopurinol has a high incidence of hypersensitivity in the Asian population. This creates a significant unmet medical need for the treatment of hyperuricemia.
Clinical Trial Results and Global Development
In a Phase II study conducted in the United States (CLUE Study), tigulixostat showed serum uric acid (sUA)-lowering effects across all dose levels and achieved a treatment target of sUA<5mg/dL as the primary endpoint at month three with all dose groups when compared with placebo and febuxostat. LG Chem has initiated multi-regional global Phase III clinical trials for the drug in Q4 2022, positioning tigulixostat as a potential game-changer in the treatment of hyperuricemia and gout.-Fineline Info & Tech