Lingke Pharmaceuticals completes patient enrolment in phase III trial of zaprixitinib for the treatment of ankylosing spondylitis

Lingke Pharmaceutical (Zhejiang) Co., Ltd. (Lingke Pharmaceutical), a clinical-stage innovative drug development company focused on autoimmune and inflammatory diseases, announced that its core product, zaprixitinib capsules, for the treatment of active ankylosing spondylitis, completed enrollment of all subjects on July 9. This successful progress marks a key stage in the development of zaprixitinib in the field of ankylosing spondylitis, and is expected to provide patients with a new oral treatment option for this chronic inflammatory disease.

This phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of zaprexitinib in patients with active ankylosing spondylitis. The primary endpoint is the proportion of participants achieving the American Society for Spondyloarthritis Assessment (ASAS40) improvement at week 16. Currently, all 352 participants have been enrolled, and the study is progressing as planned with subsequent treatment, follow-up, and data collection.

Ankylosing spondylitis is a chronic, progressive inflammatory disease that primarily affects the spine and sacroiliac joints, causing pain, stiffness, and limited function, severely impacting patients' quality of life. Although current treatment options include nonsteroidal anti-inflammatory drugs (NSAIDs) and biologics, a significant proportion of patients do not achieve adequate remission or face safety concerns regarding long-term medication, indicating a significant unmet clinical need.

Zapxitinib is a second-generation selective JAK1 inhibitor with ""best-in-class"" potential. Compared to first-generation JAK inhibitors with lower selectivity, zapxitinib has higher selectivity for JAK1, which can reduce the safety risks caused by off-target effects while ensuring efficacy.

Preclinical and clinical studies have demonstrated that zaprexitinib exhibits potent and dose-dependent inhibition of multiple JAK1-related inflammatory signalling pathways, thus demonstrating promising efficacy potential across various indications. Previously released data from a phase III 24-week study in rheumatoid arthritis and a phase III 52-week study in atopic dermatitis showed that zaprexitinib met both primary and key secondary endpoints, demonstrating rapid and sustained efficacy, as well as good safety and tolerability. The incidence of serious adverse events and adverse events of particular concern (AESIs) was comparable to that of placebo, and laboratory safety indicators also showed excellent performance.

Dr. Wu Yu, clinical lead at Lingke Pharmaceuticals, stated, ""Zepresitinib has demonstrated positive efficacy and good safety in Phase III studies of rheumatoid arthritis and atopic dermatitis. We look forward to this study further validating its efficacy and safety in patients with ankylosing spondylitis, providing solid clinical evidence for subsequent registration applications.""

Dr. Wan Zhaokui, founder, chairman, and CEO of Lingke Pharmaceuticals, stated, ""The completion of enrollment for all subjects in the phase III study of ankylosing spondylitis is another important milestone in the development of zaprexitinib. We look forward to this study validating the clinical value of zaprexitinib in this indication and bringing a safer and more effective oral treatment option to patients as soon as possible.""

Lingke Pharmaceuticals is a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases. It is committed to addressing unmet clinical needs through original innovation; developing innovative small-molecule therapies with differentiated advantages; and providing superior alternatives to oral treatments for biologics.

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