Guangdong Taienkang Pharmaceutical Co., Ltd, (SHE: 301263), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a Phase II clinical trial filing for its CKBA ointment in the treatment of vitiligo. The Category 1 chemical drug is also currently undergoing a Phase IIa clinical study for mild to moderate plaque psoriasis.
Understanding Vitiligo and Its Global Impact
Vitiligo is an autoimmune skin disease characterized by the loss of melanocytes, leading to patchy depigmentation of the skin. It is estimated to affect 0.5% to 2% of the global population, with nearly 50% of cases appearing before the age of 20, and many before the age of 10. CKBA ointment is a locally applied formulation under development for the treatment of vitiligo and plaque psoriasis. The drug works by inhibiting the catalytic activity of acetyl CoA carboxylase (ACC1/ACC2) in a dose-dependent manner and has demonstrated good anti-inflammatory and immunomodulatory activities. Studies have shown that CKBA can inhibit the differentiation of naïve CD8+T cells into Tc1 cells, significantly inhibiting IFN-γ genesis.
CKBA Ointment’s Potential in the Chinese Market
As of 2020, there were approximately 20 million vitiligo patients in China. Notably, there is no drug approved specifically to treat the disease in the country, with glucocorticoids (TCS) and calcineurin inhibitors (TCI) being used off-label. The acceptance of the clinical trial filing for CKBA ointment by the NMPA signifies a step forward in addressing the unmet medical need for vitiligo treatment in China.-Fineline Info & Tech
