Inventisbio Co.,Ltd. has announced that its Investigational New Drug application for D-2570 as a monotherapy for psoriasis has passed the FDA's 30-day review period without objections. Consequently, the Phase II clinical trial of D-2570 for psoriasis in the United States has been officially approved. D-2570 is an novel, orally administered, selective inhibitor targeting tyrosine kinase 2, developed internally by the company for the treatment of autoimmune diseases such as psoriasis. The approved U.S. trial is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of D-2570 in patients with moderate to severe plaque psoriasis. The primary endpoint will measure the proportion of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index score by week 12. Previously, the company completed a Phase II trial of D-2570 for psoriasis in China. Results demonstrated that, compared to placebo, D-2570 showed significant efficacy in skin lesion clearance and disease severity improvement at week 12, with a favorable overall safety and tolerability profile. Encouraged by these positive efficacy and safety data, Inventisbio is actively expanding clinical exploration of D-2570 into other autoimmune disease areas. In May 2025, the company dosed the first patient in a Phase II trial for ulcerative colitis, which is currently ongoing as planned. In September of the same year, the company reached an agreement with China's National Medical Products Administration on the design of a Phase III clinical trial for D-2570 in psoriasis; patient enrollment for this registrational Phase III trial is now proceeding according to plan. Clinical studies of D-2570 for other indications, including psoriatic arthritis and systemic lupus erythematosus, are also underway as scheduled.
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