InnoCare Pharma (HKEX: 09969; SSE: 688428) announced today that the first patient has been dosed in a Phase II/III clinical trial in China evaluating its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of non-segmental vitiligo.

ICP-332 is a Class 1 innovative drug developed in-house by InnoCare with global intellectual property rights. It is a highly potent and selective oral TYK2 inhibitor designed to treat various T-cell–mediated autoimmune diseases, including vitiligo, atopic dermatitis, and prurigo nodularis, offering strong market potential. TYK2 is a non-receptor tyrosine kinase belonging to the Janus kinase (JAK) family and plays a critical role in the JAK-STAT signaling pathway, which is key to inflammatory disease mechanisms.

Vitiligo is a skin disorder caused by the destruction of melanocytes, leading to localized white patches due to melanin deficiency. The global prevalence of vitiligo is estimated at 0.5% to 2% [1]. As a chronic condition, vitiligo requires long-term treatment aimed at halting the progression of skin lesions, promoting repigmentation, and maintaining results to prevent recurrence.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, stated:
“Vitiligo places a significant psychological and social burden on patients, many of whom suffer from reduced self-esteem and social anxiety. There is currently a lack of effective treatments, and a large unmet medical need remains. We are accelerating the clinical development of Soficitinib and hope to bring meaningful benefits to patients with vitiligo and other autoimmune diseases.”

In addition to vitiligo, ICP-332 is also being rapidly developed for other autoimmune diseases. A Phase III registrational trial for the treatment of atopic dermatitis is currently progressing swiftly.

[1] Kruger and Schallreuter, 2012.