BEIJING, October 09, 2024--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that phase II clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-488 met the primary endpoint in adult patients with moderate-to-severe plaque psoriasis.

ICP-488, in psoriasis patients treated for 12 weeks, demonstrated an excellent efficacy and safety profile. ICP-488 achieved multiple efficacy endpoints including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (improvement of at least 75%, 90% and 100% in PASI score from baseline) and static Physician’s Global Assessment (sPGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in both the 6mg and 8mg dosing group respectively.

Following the 12-week treatment with 6mg or 9mg once-daily dosing of ICP-488, PASI 75 reached 77.3% and 78.6% respectively, compared to 11.6% for patients receiving placebo (p<0.0001); PASI 90 reached 36.4% and 50.0% respectively, compared to 0% for patients receiving placebo (p<0.0001); PASI 100 reached 11.4% and 11.9% respectively, compared to 0% for patients receiving placebo (p<0.05); sPGA 0/1 reached 70.5% and 71.4% respectively, compared to 9.3% for patients receiving placebo (p<0.0001).

ICP-488 demonstrated good tolerability and a favorable safety profile, with most treatment emergent adverse events (TEREs) and treatment-related adverse events (TRAEs) being mild or moderate.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, " Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments. We are excited to see the positive results from the phase II study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases."

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 to 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.