Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a multi-center, randomized double-blinded, placebo parallel controlled Phase II clinical study for its jakinib, a Janus kinase (JAK) inhibitor, in patients with active ankylosing spondylitis (AS). The study demonstrated robust results, meeting the pre-set statistical standards and showing significant improvements in key efficacy indicators.
Clinical Trial Results
At 16 weeks of treatment, the percentage of patients achieving an ankylosing spondylitis 20% response (ASAS20) was 62.9% for the jakinib 100 mg Bid group, 59.4% for the 75 mg Bid group, and 33.3% for the placebo control group. These results met the pre-set statistical standard. Important secondary efficacy indicators also showed significant improvements, with the ASAS40 ratio being 55.2% for the jakinib 100 mg Bid group, 48.1% for the 75 mg Bid group, and 20.0% for the placebo group.
Future Development Plans
Zelgen plans to conduct key registration clinical trials after communicating with the Center for Drug Evaluation (CDE) in a pre-phase III communication. This next step is crucial in advancing jakinib as a potential new treatment option for patients with ankylosing spondylitis.
Understanding Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily affects the sacroiliac joints, vertebral condyles, paraspinal soft tissues, and peripheral joints. It can also be accompanied by extra-articular manifestations. In severe cases, spinal deformity and ankylosis may occur. The prevalence of ankylosing spondylitis varies by country, with a preliminary survey indicating a prevalence of about 0.3% in China.
Mechanism of Action
Jakinib works by blocking the signal transducer and activator of transcription (STAT) and JAK signaling pathways, thereby improving immune-related inflammatory effects. This mechanism of action makes jakinib a promising candidate for treating the chronic inflammation associated with ankylosing spondylitis.-Fineline Info & Tech
