InnoCare Pharma has announced that registrational phase III clinical study results of novel TYK2 (tyrosine kinase 2) inhibitor soficitinib (ICP-332) met the primary endpoint in patients with moderate-to-severe atopic dermatitis (AD).
The phase III study is a randomised, double-blind, placebo-controlled, multicentre registrational clinical trial designed to evaluate the efficacy, safety and tolerability of soficitinib in patients with moderate-to-severe AD.
The study demonstrated that soficitinib achieved the primary endpoint with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures.
Soficitinib also showed a good safety profile, consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data from the study will be presented at upcoming international scientific congresses and/or academic journal.
Soficitinib is a potent and selective oral TYK2 inhibitor being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, psoriasis, nodular prurigo and chronic spontaneous urticaria, etc. TYK2 plays a key role in the JAK-STAT signalling pathway and is critical in the pathogenesis of inflammatory diseases.
Jasmine Cui, co-founder, chairwoman and CEO of InnoCare, said: “We are happy to see that soficitinib has met the primary endpoint in the Phase III studies in atopic dermatitis with excellent clinical results. AD is a chronic, relapsing inflammatory skin disease characterized by intense pruritus, eczema and substantial impairment in patients’ quality of life. We will continue to complete the Phase III study, and plan to advance the regulatory filing to bring better treatment option to patients with atopic dermatitis and other autoimmune diseases.”
According to the WHO Global Burden of Disease study, AD affects as many as 230m people globally, ranking first in disease burden among non-fatal diseases worldwide. In China, the number of patients with AD is nearly 70m, and the prevalence is increasing year by year.