Professor Honglin Wang from Shanghai General Hospital Gains Approval for Phase II Clinical Trials of Groundbreaking CKBA Ointment for Vitiligo

Link of the original article: https://mp.weixin.qq.com/s/eqoZVZXS1FoFhXoivWfe6g

On July 24, Professor Honglin Wang, Executive Vice President of Clinical Research Institute and Director of the Precision Research Center for Intractable Diseases at Shanghai General Hospital, was granted approval by the National Medical Products Administration to commence Phase II clinical trials for the CKBA ointment. This treatment is intended for non-segmental (common type) vitiligo.

CKBA, a novel anti-inflammatory entity, is derived from active components extracted and altered from traditional Chinese medicine, specifically frankincense. This formulation is the result of almost two decades of meticulous research and development on autoimmune diseases by Professor Wang's team. This groundbreaking compound marks the first original new drug candidate in China to independently progress to Phase II clinical trials for vitiligo treatment. Given the lack of effective vitiligo treatments currently available on the Chinese market, the introduction of novel drugs for this condition holds profound significance.

In April 2019, the National Medical Products Administration authorized the clinical trial of CKBA ointment for the topical treatment of mild to moderate psoriasis. The ointment has since successfully navigated Phase I clinical trials and multi-center Phase IIa clinical research, exhibiting notable systemic and local tolerance, along with positive therapeutic tendencies in target tissues.

Recent discoveries by Professor Wang's team suggest that CKBA significantly ameliorates white spot symptoms in vitiligo animal models. It achieves this by impeding the proliferation of melanocyte-specific cytotoxic T cells and curtailing the secretion of the pathogenic factor interferon-gamma. Mechanistically, CKBA diverges from other investigational drugs, primarily Jak inhibitors, by inhibiting the catalytic activity of acetyl-CoA carboxylase (ACC1/ACC2) and modulating the fatty acid metabolism pathway in a dose-dependent fashion. This regulation impacts the killing function of memory CD8+ T cells in the skin tissue. On May 10 of this year, the team was granted the acceptance notice for the clinical trial of CKBA ointment with additional indications for vitiligo and later received authorization to initiate Phase II clinical trials for the treatment of non-segmental vitiligo with the CKBA ointment.

Vitiligo is a skin condition that causes pigment loss, is recurrent in nature, and has a low cure rate. The disease can lead to severe visible skin damage, potentially creating social interaction difficulties and significantly affecting one's quality of life. Current estimates suggest that China has approximately 30 million vitiligo patients, with 63.4% being under the age of 20. Based on the progress of the Phase II clinical trials for vitiligo, Professor Wang's team plans to apply for breakthrough therapy designation, hoping to enhance the range of new vitiligo drugs as swiftly as possible, and to offer more treatment alternatives for patients.