InnoCare administers first dose to patient in Phase II trial of soficitinib

InnoCare has administered the first dose of its selective and potent tyrosine kinase 2 (TYK2) inhibitor, soficitinib (ICP-332), in a global Phase II clinical trial targeting prurigo nodularis in China. Soficitinib is being developed to address a range of T-cell mediated autoimmune disorders, including prurigo nodularis, atopic dermatitis, vitiligo, and urticaria, focusing on unmet needs in dermatology.

TYK2 plays a crucial role in the JAK-STAT signaling pathway and contributes to the development of inflammatory conditions. Prurigo nodularis, a chronic inflammatory skin disease, is marked by itchy nodules that significantly impair patient quality of life. Soficitinib functions by inhibiting cytokine pathways such as IL-4, IL-13, and IL-31, thereby reducing skin inflammation and mitigating neurogenic itch.

Dr. Jasmine Cui, co-founder, chairwoman, and CEO of InnoCare, stated: Our pipeline now addresses ten major autoimmune diseases, with a particular focus on dermatological conditions. The Phase II trial of Soficitinib for moderate-to-severe atopic dermatitis demonstrated exceptional efficacy and a favorable safety profile. Results were presented as a late-breaking oral session at the American Academy of Dermatology (AAD) Annual Meeting. We are committed to accelerating global development to deliver innovative therapies to autoimmune patients as quickly as possible.

InnoCare specializes in developing treatments for cancers and autoimmune diseases with high unmet medical needs worldwide. The company operates in Beijing, Guangzhou, Hong Kong, Nanjing, Shanghai, and the United States. In July 2025, the China National Medical Products Administrations Center for Drug Evaluation (CDE) approved the investigational new drug application for ICP-B794, a B7-H3-targeted antibody-drug conjugate, allowing the initiation of clinical trials.

Source: Clinical Trials Arena, GlobalData

Author's Opinion: A Step Forward in Autoimmune Disease Treatment

The recent announcement by InnoCare regarding the administration of the first dose of soficitinib (ICP-332) in a Phase II clinical trial marks a significant milestone in the treatment of prurigo nodularis and other T-cell mediated autoimmune diseases. The move reflects InnoCare's ongoing commitment to developing innovative therapies that address the unmet needs in dermatology, a field that has long been underserved. Soficitinib, by targeting crucial cytokine pathways, holds the potential to reduce inflammation and alleviate neurogenic itch, which is one of the most challenging symptoms of prurigo nodularis.

What stands out from InnoCare’s approach is the broad scope of its pipeline. InnoCare is not only addressing dermatological conditions like prurigo nodularis, but also other significant autoimmune diseases such as atopic dermatitis, vitiligo, and urticaria. The successful Phase II trial of soficitinib for atopic dermatitis further reinforces the promise of this drug in treating a variety of skin conditions, and its favorable safety profile offers hope for long-term use in patients.

InnoCare's approach to accelerate global development is commendable, especially as autoimmune diseases continue to challenge the global healthcare system. With its focus on global markets, including China and the United States, InnoCare appears well-positioned to make a considerable impact. If successful, soficitinib could not only transform the treatment landscape for autoimmune diseases but also potentially improve the lives of millions who suffer from debilitating skin conditions.

Sources:

• InnoCare doses first patient in Phase II trial of soficitinib