InnoCare Announces Phase II Study Results of TYK2 Inhibitor ICP-488 Meet Primary Endpoint in Psoriasis Patients

BEIJING--(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.

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.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

Forward-looking Statement

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

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