Innocare has announced that its internally developed, novel oral tyrosine kinase 2 (TYK2) inhibitor, soficitinib (ICP-332), has successfully met the primary endpoint in its Phase III registration trial for treating patients with moderate-to-severe atopic dermatitis.

This Phase III study was a randomized, double-blind, placebo-controlled, multicenter registration clinical trial designed to evaluate the efficacy, safety, and tolerability of soficitinib (ICP-332) in adult patients with moderate-to-severe atopic dermatitis.

The results demonstrate that soficitinib (ICP-332) achieved the primary endpoint with statistical significance and delivered a clinically meaningful improvement.

Furthermore, the trial also successfully met multiple secondary endpoints, indicating a consistent therapeutic effect across various efficacy evaluation measures.

Detailed efficacy and safety data from this study will be presented at future international academic conferences and submitted for publication in peer-reviewed medical journals.

The safety profile of soficitinib (ICP-332) was consistent with findings from prior clinical studies, with no new safety signals identified.

The company plans to complete the ongoing Phase III study, which includes long-term safety follow-up, and intends to advance the regulatory submission for soficitinib (ICP-332) for the treatment of moderate-to-severe atopic dermatitis upon study completion.