Innovent and LG Chem Announce Strategic Collaboration for Tigulixostat, a Novel Non-Purine Xanthine Oxidase Inhibitor for the Treatment of Gout Disease
Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, and LG Chem Life Sciences (“LG Chem”), a division of LG Chem, announced that the two parties have entered into a strategic collaboration and license agreement regarding LG Chem’s Tigulixostat (LG R&D code: LC350189, Innovent R&D code: IBI350), a late-stage novel non-purine xanthine oxidase inhibitor (“XOI”) for the chronic management of hyperuricemia in patients with gout disease.
In Phase 2 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 3 with all dose groups when compared with placebo as well as with Febuxostat. LG Chem has initiated multi-regional global Phase 3 clinical trials for Tigulixostat in Q4 2022.
Under the terms of the agreement, Innovent will obtain an exclusive right to develop and commercialize Tigulixostat in China. LG Chem will receive totaling up to $95.5 million for the China rights including $10 million upfront payment, milestones, plus tiered royalties on net sales of product in China.
Hyperuricemia is one of the most prevailing chronic disease globally with a huge patient population. Prevalence rate of hyperuricemia is as high as 13.3% in China. Moreover, hyperuricemia is the predisposing condition for gout, and the number of hyperuricemia patients with gout symptoms is up to 15.5 million in China. Febuxostat and Allopurinol as XOI inhibitors, are current therapies recommended for the treatment of hyperuricemia including gout, but contain clear limitations: Febuxostat has potential cardiovascular risk and Allopurinol could cause high incidence of hypersensitivity in Asian population. Under these circumstances, there exists a huge unmet medical need for the treatment of hyperuricemia.
Dr. Yong Jun Liu, President of Innovent, stated: “We are delighted to enter this strategic collaboration with LG Chem on Tigulixostat. As hyperuricemia and gout is both a rheumatic disease and a metabolic disease, the collaboration fits into Innovent’s strategic portfolio planning in rheumatic and metabolic areas, as well as creates great synergy with our current pipeline, development resources and commercial network. As one of the few next generation XOI drugs in development, Tigulixostat has demonstrated higher efficacy compared to Febuxostat in exploratory analysis and favorable safety profile in the phase 2 study, showing the great best-in-class potential in the treatment of gout. We will work closely with LG Chem to facilitate the development of Tigulixostat, and we hope to bring the novel product to the market as quickly as possible.”
Dr. Jeewoong Son, President of LG Chem Life Sciences Company, stated: “Tigulixostat will provide a better treatment option for gout patients in near future, and our collaboration with Innovent will accelerate the global development of Tigulixostat with the goal of bringing a potentially impactful treatment option to the patient with high unmet medical needs. We are very excited to enter into this strategic collaboration which is a major milestone for LG Chem as we are building global biotechnology and R&D capabilities, and hope to maximize the potential of Tigulixostat through this collaboration. We look forward to collaborating with Innovent to expedite the development of Tigulixostat and to commercialize the new XOI drug, based on the strong and broad experience and expertise of both companies.”