23 August 2023 | Wednesday | News
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The study, led by Professor Xiaofeng Zeng, the director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, involved a randomized, double-blind, placebo-controlled, multicenter Phase II trial conducted in adult patients with active ankylosing spondylitis (AS) who had inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or were NSAID-intolerant. A total of 177 patients were enrolled in the trial and randomly assigned to three groups in a 1:1:1 ratio, including LNK01001 high-dose, low-dose, and placebo groups. The primary efficacy endpoint of the study was achieving an ASAS40 response at Week 12.
Preliminary efficacy data indicates that after 12 weeks of treatment, both the high and low dose groups of LNK01001 showed a statistically significant difference in the proportion of patients achieving an ASAS40 response compared to the placebo group, reaching the primary endpoint. The improvement in other efficacy indicators is consistent with the primary endpoint. Moreover, LNK01001 demonstrated a rapid onset of action, with response rates for various efficacy endpoints in both the high and low dose groups of LNK01001 showing varying degrees of improvement starting from the second week.
In terms of safety, both high and low dose groups of LNK01001 demonstrated good overall safety and tolerability, with the majority of treatment-emergent adverse events (TEAE) falling within CTCAE grade 1-2. During the placebo-controlled period (weeks 0-12), the occurrence of TEAEs of grade 3 or above, TEAEs leading to discontinuation, and serious adverse events (SAEs) was low and comparable to the placebo group. Throughout the entire study duration (weeks 0-24), no major adverse cardiovascular events (MACE), venous thromboembolism (VTE), or severe safety events such as malignancies were reported.
Professor Xiaofeng Zeng, the principal investigator of this study said, "Ankylosing spondylitis is a chronic inflammatory disease primarily affecting the spine and sacroiliac joints. Controlling or reducing inflammation, relieving pain, and stiffness are the main treatment goals. LNK01001 has demonstrated both efficacy and safety in this study, and we look forward to further validating its efficacy and safety in Phase III clinical trials to benefit more patients."
"Ankylosing spondylitis, which predominantly affects young and middle-aged individuals, significantly impairs patients' mobility and quality of life. There are still many unmet treatment needs in the existing therapeutic approaches", said Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, "We are pleased to witness LNK01001's positive outcomes in this study. The company has recently submitted an End of Phase II (EOP2)/Pre-Phase III meeting application and is actively advancing the Phase III clinical trial of LNK01001 for the treatment of ankylosing spondylitis, aiming to provide an improved treatment option for patients."
Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, 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 favorable 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."