InnoCare's TYK2 Inhibitor ICP-488 Meets Phase II Psoriasis Study Endpoint

BEIJING, China I October 09, 2024 I InnoCare Pharma, a prominent biopharmaceutical enterprise specializing in cancer and autoimmune disease treatments, has announced that its phase II clinical study of the innovative TYK2 inhibitor ICP-488 has reached its primary goal in adult patients suffering from moderate-to-severe plaque psoriasis.

When administered to psoriasis patients for a duration of 12 weeks, ICP-488 displayed exceptional efficacy and safety. It met multiple efficacy benchmarks, such as Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, and static Physician’s Global Assessment (sPGA) 0/1. These results were observed in both the 6mg and 8mg dosing groups.

Following 12 weeks of treatment with daily doses of either 6mg or 9mg of ICP-488, notable improvements were recorded. PASI 75 was achieved by 77.3% and 78.6% of patients, respectively, compared to 11.6% of those on a placebo. For PASI 90, 36.4% and 50.0% of patients reached this benchmark, in contrast to 0% for the placebo group. PASI 100 was attained by 11.4% and 11.9% of patients in the treatment groups compared to none in the placebo group. The sPGA 0/1 metric showed that 70.5% and 71.4% of patients had significant improvement, compared to 9.3% for the placebo group.

The safety profile of ICP-488 was favorable, with most adverse events being mild or moderate in nature, while demonstrating good tolerability.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, remarked on the necessity for new treatments for psoriasis, noting the chronic nature of the disease and the substantial unmet medical need. She expressed enthusiasm about the positive phase II results of ICP-488 and indicated plans to advance its clinical development to assist patients with psoriasis and other autoimmune conditions.

The study was a multicenter, randomized, double-blind, placebo-controlled phase II trial seeking to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients participated in the study, being randomly allocated to one of three groups: 6mg once-daily, 9mg once-daily, or a placebo group, over a 12-week treatment period.

ICP-488 is a potent and selective oral TYK2 allosteric inhibitor. By attaching to the JH2 domain, it disrupts the signal transduction of inflammatory cytokines such as IL-23, IL-12, and type 1 IFN, thereby halting the pathological progression of autoimmune and inflammatory diseases.

Currently, it is estimated that around seven million individuals in China live with psoriasis, a number that continues to grow. Present treatment options do not fully meet the needs of those affected, indicating a significant gap in available therapies. There is especially high demand for new oral medications, as many patients with moderate-to-severe psoriasis are either undertreated or not treated at all.

InnoCare is dedicated to discovering, developing, and commercializing first-in-class and best-in-class drugs to address unmet medical needs in cancer and autoimmune diseases in China and globally. The company operates branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.