Lynk Pharmaceuticals has reported positive topline results from a Phase II clinical trial evaluating LNK01001 in adults with ankylosing spondylitis (AS).
The multicentre, placebo-controlled, double-blind, randomised study was led by Peking Union Medical College Hospital and Chinese Academy of Medical Sciences Rheumatology and Immunology department director Xiaofeng Zeng.
It enrolled a total of 177 patients who had inadequate responses to non-steroidal anti-inflammatory drugs (NSAIDs) or were intolerant to them.
They were randomised into three groups to receive either a high or low dose of LNK01001 or a placebo for 12 weeks.
After 12 weeks of treatment, both the treatment groups showed a statistically significant difference in ASAS40 response in comparison to a placebo, reaching the primary endpoint.
Both groups also showed improvements starting from the second week, with a rapid onset of action and response rates for various efficacy endpoints.
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In addition, LNK01001 demonstrated good overall safety and tolerability.
No venous thromboembolism, major adverse cardiovascular events, or severe safety events, such as malignancies, were observed throughout the study duration.
Lynk Pharmaceuticals chairman and CEO Dr Zhao-Kui (ZK) Wan said: “As a highly selective JAK1 inhibitor, LNK01001 has successfully completed multiple Phase Ib and Phase II clinical trials in almost 600 patients for three indications (rheumatoid arthritis, atopic dermatitis, and ankylosing spondylitis), with about 800 subjects exposed to LNK01001.
“All studies conducted have shown promising results up to date. We are delighted to observe the significant efficacy and favourable safety profile demonstrated by LNK01001 in these studies.
“We are gearing up to initiate Phase III clinical trials for LNK01001 in the near future to accelerate the clinical development and regulatory process for this product and, at the same time, to explore the potential of additional indications.”