Clinical Trial Update

Lynk Pharmaceuticals Announced First Patient Dosed In Phase II Clinical Study Of LNK01001

December 02,2021 09:56 AM
- By Admin

HANGZHOU, ChinaDec. 1, 2021 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced the company has dosed the first patient with LNK01001 in its Phase II clinical trial in subjects with rheumatoid arthritis (RA). LNK01001 is a targeted inhibitor for the treatment of autoimmune diseases.

The clinical study is designed to evaluate the safety and efficacy of LNK01001 in subjects with moderate to severe active rheumatoid arthritis who have poor response with or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

LNK01001 is the first innovative drug developed by Lynk Pharmaceuticals, and is a selective kinase inhibitor for the treatment of autoimmune diseases. Previously, LNK01001 completed Phase I clinical studies in healthy subjects in the summer of this year in China and in Australia and Japan, sponsored by Lynk Pharmaceuticals and its US partner, respectively. The results demonstrated that the drug is safe and well tolerated. In addition, LNK01001 was approved by the National Medical Products Administration of China (NMPA) for the clinical evaluation of new indications -- ankylosing spondylitis (AS) and atopic dermatitis (AD).

Professor Xiaofeng Zeng, the principal investigator of this study and the director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, said, "Rheumatoid arthritis is a chronic and progressive autoimmune disease, if not treated in time, it will cause disability and systemic complications, seriously affecting the patients' quality of life and physical health. LNK01001has demonstrated a good safety profile and a positive PD marker response in the Phase I studies, I am happy to lead the Phase II clinical trial along with many excellent clinicians, and we will do our best to bring a new treatment for the patients as soon as possible."

"Rheumatoid arthritis is a chronic, generally progressive autoimmune disease that causes functional disability, significant pain and joint destruction, and leads to premature mortality. Globally, this disease has a heavy disease burden and its clinical demands for an optimal therapy for the disease management are far from being satisfied. The results of our Phase I clinical research of LNK01001 have shown favorable safety profile and tolerability." Dr. Sherry Weigand, the chief medical officer of Lynk Pharmaceuticals, said, "achieving the first patient in for the Phase II clinical trial of LNK01001 is a major milestone for the development of the LNK01001, and we expect that this innovative drug can bring new treatment options for RA disease management."

About Lynk Pharmaceuticals:

Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed a number of Class I clinical innovative new drugs, and independently as well as jointly with its US partner launched a number of clinical studies globally.