InnoCare Announces the Completion of Patient Enrollment in the Phase II Clinical Trial of ICP-488 for the Treatment of Psoriasis

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, today announced the completion of patient enrollment for the phase II clinical trial of ICP-488, a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, for the treatment of psoriasis.

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment.

ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. ICP-488 has demonstrated good efficacy and safety in the phase I study of treating psoriasis patients.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, "Psoriasis requires long-term management, and there is still a significant unmet demand for new drugs, especially oral medications in its treatment. We are very pleased to see the completion of patient enrollment in the phase II clinical trial for the treatment of psoriasis with ICP-488. We remain committed to diligently advancing the clinical development of this promising therapy, with the goal of providing improved treatment options to psoriasis patients as soon as possible.

Recent data indicates that approximately seven million people in China are currently living with psoriasis¹, and this number is on the rise². Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications. Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether³.

1 Epidemiological Investigation on Psoriasis

2 2021.  Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021.

3 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018). Chinese Journal of Dermatology. 2019. Research on the Situation of Psoriasis Healthcare in China based on the Global Monitoring Project of Psoriasis and the Causal Relationship between Psoriasis and Obesity and Type II Diabetes. 2020