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-332 met primary endpoint in adult patients with moderate-to-severe atopic dermatitis (AD).
ICP-332 in AD patients treated for 4 weeks demonstrated excellent efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints including Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90 (improvement of at least 50%, 75% and 90% in EASI score from baseline) and Investigator’s Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in 80mg and/or 120mg dosing groups respectively.
The mean percentage change from baseline in the EASI score reached 78.2% and 72.5% at once-daily dosing group of 80mg and 120mg respectively, both with a highly significant P value (p<0.0001), compared to 16.7% for patients receiving placebo. EASI 75 reached 64% and 64% at 80 mg and 120 mg dosing group respectively, compared to 8% percent for patients receiving placebo (p<0.0001).
ICP-332 showed a good tolerability and safety profile, treatment-related adverse events (TRAEs) were mild or moderate, which is comparable to those receiving placebo.
Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnnoCare, said, “The AD has huge unmet medical needs, and we are excited to see the positive results from the phase II study of ICP-332. We will further accelerate the clinical development to benefit patients with AD and other autoimmune diseases.”
By now, there is no TYK2 inhibitor approved for the AD globally. According to the source of Pharma Intelligence, AD has become a major autoimmune disease with a global market potential of US$10 billion by 20301.
The study is a randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of ICP-332 in patients with moderate-to-severe atopic dermatitis.
As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway in T cells, playing an important role in the pathogenesis of inflammatory diseases. ICP-332 is a potent and selective TYK-2 inhibitor with about 400 folds of selectivity against JAK2 to avoid the adverse events associated with non-selective JAK inhibitors.