China-based Lynk Pharmaceuticals Co., Ltd has announced positive topline results from the Phase II clinical study of its pipeline candidate, LNK01001, in the treatment of ankylosing spondylitis (AS). The randomized, double-blind, placebo-controlled, multi-center study involved 177 AS patients who had previously experienced insufficient efficacy or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs). Patients were divided into three groups to receive high and low doses of LNK01001 or a placebo, with the primary efficacy endpoint being the proportion of subjects achieving an ASAS40 response at 12 weeks of treatment.
Preliminary Efficacy Data and Rapid Onset of Action
Preliminary efficacy data revealed that at 12 weeks, both high and low dose groups of LNK01001 demonstrated a statistically significant difference in achieving ASAS40 response compared to the placebo group, meeting the primary endpoint. Other efficacy indicators also showed consistent improvement. LNK01001 exhibited a rapid onset of action, with therapeutic endpoint response rates in both dose groups showing varying degrees of improvement from the second week onwards.
Safety and Tolerability Profile
In terms of safety, LNK01001 showed good overall safety and tolerability in both high and low dose groups, with the majority of treatment emergent adverse events (TEAEs) classified as CTCAE 1-2. During the placebo control period (0-12 weeks), the incidence of TEAEs at level 3 and above, TEAEs leading to discontinuation, and severe adverse events (SAEs) was low and comparable to the placebo group. Over the entire study period (0-24 weeks), there were no reports of major adverse cardiovascular events (MACE), thromboembolic events, or serious safety events such as malignant tumors.
LNK01001’s Clinical Progress and Upcoming Phase III Trials
LNK01001, a highly selective JAK1 inhibitor, has successfully concluded Phase Ib and II clinical studies in rheumatoid arthritis, atopic dermatitis, and AS, with all yielding positive results. The company is set to commence Phase III trials for LNK01001 in the near future.-Fineline Info & Tech
