Lynk Pharmaceuticals has completed dosing of the first patient in a Phase II clinical trial evaluating its investigational LNK01004 ointment for the treatment of Vitiligo, marking a key milestone in the development of the topical therapy.
The first patient was enrolled and dosed on June 30 in the randomized, double-blind, vehicle-controlled, parallel-group study, which is designed to assess the efficacy and safety of LNK01004 ointment in adult patients with vitiligo. The multicenter trial is being conducted across China under the leadership of Jianzhong Zhang and Cheng Zhou from the Department of Dermatology at Peking University People’s Hospital.
LNK01004 ointment is a soft pan-Janus kinase (JAK) inhibitor designed to modulate multiple inflammatory cytokine-related signalling pathways simultaneously while limiting drug exposure primarily to the skin.
“Unlike conventional JAK inhibitors, LNK01004 is designed with low systemic exposure and skin-restricted distribution, maintaining pan-JAK inhibitory activity while largely confining drug exposure to skin tissue to achieve an optimal balance between efficacy and safety,” the company said.
Preclinical and early clinical studies have demonstrated encouraging efficacy, favourable safety e and skin-restricted distribution of the investigational therapy.
Beyond vitiligo, Lynk Pharmaceuticals is also advancing the clinical development of LNK01004 for other inflammatory skin conditions, including chronic hand eczema, as part of its expanding dermatology pipeline.
Dr. Henry Wu, who is responsible for overseeing and directing the overall clinical research programme, said patients with vitiligo experience not only skin depigmentation but also significant psychological and social challenges.
“Through this Phase II clinical study, we look forward to further evaluating the efficacy and safety of LNK01004 in patients with vitiligo and generating robust clinical evidence to support subsequent pivotal clinical trials,” he said.
Dr. Zhao-Kui (ZK) Wan, Founder, chairman and CEO of Lynk Pharmaceuticals, described the successful dosing of the first patient in the Phase II trial for vitiligo as “an important milestone in the clinical development of the programme.”
“With its differentiated skin-restricted molecular design and ability to modulate multiple inflammatory pathways, we believe LNK01004 has the potential to provide patients with vitiligo a novel therapeutic option that combines efficacy, safety, and long-term treatment convenience,” he added.
Last month, Lynk Pharmaceuticals received approval from China’s National Medical Products Administration (NMPA) to initiate Phase II clinical trials of LNK01004 ointment for the treatment of Vitiligo and Chronic hand eczema.
Vitiligo is an autoimmune skin disorder that causes depigmented or hypopigmented patches on the skin. There is currently no cure for the condition, and current treatments primarily focus on halting disease progression, promoting skin repigmentation and preventing relapse.
Chronic hand eczema is a recurrent inflammatory skin disease characterized by redness, blisters, scaling and intense itching. Treatment options for patients with moderate-to-severe or persistent chronic hand eczema remain limited, highlighting a significant unmet medical need.
