Soficitinib(ICP-332): An Oral TYK2-JH1 Inhibitor, A Potential Blockbuster
TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway, playing an important role in the pathogenesis of T-cell inflammatory diseases.
Soficitinib (ICP-332) met the primary endpoint in patients with moderate-to-severe AD in registrational phase III clinical study , demonstrating statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures.
Soficitinib (ICP-332) met the primary endpoint in patients with moderate-to-severe atopic dermatitis (AD). Soficitinib also showed a good safety profile, which was consistent with previous clinical studies, and no new safety signals were identified.
The current indications of soficitinib under development include AD, vitiligo, psoriasis, nodular prurigo and chronic spontaneous urticaria, etc.
•Soficitinib demonstrated an outstanding efficacy and safety profile in Phase II study. ICP-332 achieved multiple efficacy endpoints in the 80 mg QD and 120 mg QD dosing groups respectively, including the percentage change in Eczema Area and Severity Index (EASI) score from baseline, EASI 50, EASI 75, EASI 90, etc.
• The mean percentage change from baseline of the EASI score reached 78.2% and 72.5% at the 80 mg QD and 120 mg QD groups respectively, compared to 16.7% for the patients receiving placebo. The percentages of patients achieving at least 75% improvement in EASI 75 were significantly higher in the ICP-332 80 mg QD (64.0%, p<0.0001) and 120 mg QD (64.0%, p<0.0001) groups than that of placebo (8.0%), which are better than the reported efficacies of multiple approved innovative drugs treated for 12 weeks or 16 weeks (not a head-to-head comparison).
• Soficitinib was safe and well tolerated in AD patients, similar to placebo.
Fadeucravacitinib（ICP-488）: A Potential Blockbuster as an Oral TYK2-JH2 Inhibitor
Fadeucravacitinib achieved the primary endpoint in the registrational Phase III clinical study in patients with moderate-to-severe plaque psoriasis with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures.
• Phase II clinical study results showed 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).
• Fadeucravacitinib demonstrated good tolerability and a favorable safety profile, with most treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) being mild or moderate.
• The current indications of fadeucravacitinib under development include psoriasis, CLE, Sjögren’s syndrome, etc.
