Lynk Pharmaceuticals Doses First Patient in Phase II Trial of LNK01004 Ointment for Vitiligo

Lynk Pharmaceuticals Doses First Patient in Phase II Trial of LNK01004 Ointment for Vitiligo

Lynk Pharmaceuticals Advances Vitiligo Clinical Program

Lynk Pharmaceuticals Co. Ltd. has announced that the first patient has been successfully dosed in its Phase II clinical trial evaluating LNK01004 ointment for the treatment of vitiligo.

The first patient received treatment on June 30, marking an important milestone in the development of the company's investigational therapy. Lynk Pharmaceuticals is developing LNK01004 as a potential new treatment for people living with vitiligo, an autoimmune skin condition that causes patches of skin to lose their natural color.

Phase II Trial to Evaluate Safety and Effectiveness

The Phase II study is a randomized, double-blind, vehicle-controlled, parallel-group clinical trial.

The study has been designed to evaluate both the safety and effectiveness of LNK01004 ointment when applied topically in adults with vitiligo.

The clinical trial is being led by Professor Jianzhong Zhang and Professor Cheng Zhou from the Department of Dermatology at Peking University People's Hospital.

The study is currently being conducted across several clinical research centers throughout China.

LNK01004 Uses a Skin-Targeted Approach

LNK01004 is a soft pan-JAK inhibitor that has been designed to target inflammatory pathways involved in skin diseases.

Unlike conventional JAK inhibitors that may circulate throughout the body, LNK01004 has been developed to remain mainly within the skin while keeping overall drug exposure in the bloodstream low.

According to the company, this skin-restricted approach is intended to maintain treatment effectiveness while reducing the possibility of systemic side effects.

Lynk Pharmaceuticals says preclinical and early clinical studies have already shown encouraging results, including promising efficacy and a favorable safety profile.

Development Continues Beyond Vitiligo

While the current Phase II study focuses on vitiligo, Lynk Pharmaceuticals is also exploring the use of LNK01004 in other inflammatory skin conditions.

The company is actively advancing clinical development for chronic hand eczema as part of its broader dermatology pipeline.

This approach allows the company to evaluate the potential of the same investigational medicine across multiple skin diseases driven by inflammation.

Company Highlights Unmet Need in Vitiligo

Dr. Henry Wu, who oversees the overall clinical research program, said vitiligo affects much more than a person's appearance.

He explained that many patients experience long-term emotional, psychological and social challenges in addition to skin depigmentation.

According to Dr. Wu, LNK01004 was specifically designed to provide strong pan-JAK inhibitory activity while limiting drug exposure outside the skin.

He said the Phase II study will help generate important clinical evidence on the treatment's safety and effectiveness and support future pivotal clinical trials.

First Patient Dosed Marks an Important Milestone

Dr. Zhao-Kui (ZK) Wan, Founder, Chairman and Chief Executive Officer of Lynk Pharmaceuticals, described the successful dosing of the first patient as an important milestone for one of the company's key research programs.

He said the differentiated skin-restricted molecular design of LNK01004, combined with its ability to target multiple inflammatory pathways, could provide people living with vitiligo with a new treatment option that balances effectiveness, safety and long-term convenience.

The company plans to continue advancing the clinical program with the goal of making the therapy available to patients as quickly as possible.

Lynk Pharmaceuticals Continues to Expand Its Pipeline

Lynk Pharmaceuticals focuses on developing innovative small-molecule therapies for immune-mediated and inflammatory diseases.

The company was founded by experienced research and development leaders from Pfizer, MSD and Johnson & Johnson and has built its research around JAK-STAT, TYK2 signalling pathways and targeted protein degradation technologies.

Using artificial intelligence-assisted drug design, biological research platforms and translational science, the company continues to advance multiple investigational therapies through internal development and global research partnerships.

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