LYNK's LNK01001 Achieved Exciting Phase II Results in Rheumatoid Arthritis

HANGZHOU, China, May 16, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced that the Phase II clinical trial of LNK01001 in the treatment of rheumatoid arthritis (RA) showed statistically significant differences in efficacy compared with placebo in both primary and key secondary efficacy endpoints, and demonstrated good safety and tolerability. The company has applied for the pre-Phase III meeting with Center for Drug Evaluation (CDE). 

This study was a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and efficacy of LNK01001 in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerant to conventional synthetic Disease-Modifying Anti-Rheumatic Drugs. The study was led by Professor Xiaofeng Zeng, the director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital of Chinese Academy of Medical Sciences. A total of 156 patients were included in the trial. The patients were randomly divided into three trial groups at a ratio of 1:1:1, namely LNK01001 high-dose, low-dose, and placebo groups. The primary endpoint was the ACR20 response at week 12.

The study showed that both low dose and high dose groups of LNK01001 exceeded all projected primary and key secondary endpoints at week 12, showing statistically significant differences in efficacy compared with placebo; ACR20 rates of both low dose and high dose groups reached over 90% at week 24. Additionally, the overall safety and tolerability of the study drug was very good. The majority of TEAE were mild, there was no SAE reported in the active drug treatment groups.

The JAK/STAT signaling pathway is regarded as one of the central communication nodes in the cell function. Growing evidence suggested this pathway is involved in regulating various cellular mechanisms and has been found to be associated with various autoimmune diseases. Multiple JAK inhibitors have been applied to autoimmune diseases globally. According to Frost & Sullivan, the total market size of JAK inhibitors will reach $30.5 billion by 2030. LNK01001 is a highly selective JAK1 inhibitor that can selectively inhibit JAK1 without crossing over onto other JAK subtypes, particularly JAK2 enzyme, thus potentially minimizing side effects in the blood and bone marrow systems. Currently, Phase II clinical studies of LNK01001 on Ankylosing Spondylitis and Atopic Dermatitis are ongoing.

"We are very encouraged by the results of our Phase II study. It showed that LNK01001 had significant therapeutic effects and a high level of safety in the treatment of patients with rheumatoid arthritis. We are pleased to see an even more significant efficacy at 24 weeks", said Dr. Henry Wu, Chief Development Officer of Lynk, "The company has submitted EOP2/Pre-Phase III meeting request to CDE. We look forward to communicating with the regulatory authorities about the key aspects of the study. We will align our resources and speed up the phase III clinical trials of LNK01001, and to provide an additional treatment option for 5 million patients with rheumatoid arthritis in China and many more patients globally in the future."

Phase I studies in healthy volunteers of LNK01001 was completed in Australia, and demonstrated a consistent result as that in China. An extended release (ER) formulation has been successfully developed. Lynk is now actively looking for a partner to develop LNK01001 in global markets.

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 several innovative new drugs and successfully and completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.