#China #Hangzhou #rheumatoid arthritis #Lynk Pharmaceuticals #Zemprocitinib

Lynk Pharmaceuticals Unveils Promising Phase III Trial Data for Zemprocitinib

Lynk Pharmaceuticals Co., Ltd., an innovative drug development company based in China, has announced positive topline results from its Phase III clinical trial evaluating Zemprocitinib (LNK01001) in patients with moderate to severe active rheumatoid arthritis (RA). This announcement marks a significant milestone not only for the company but for the field of rheumatology. The trial met its primary and key secondary efficacy endpoints, demonstrating statistically significant improvements compared to a placebo (P < 0.0001).

Details of the Study

Conducted as a randomized, double-blind, placebo-controlled Phase III trial (CTR20232969, NCT06276998), the study aimed to assess the safety and efficacy of Zemprocitinib in patients who had previously experienced inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARDs). Led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital, the trial enrolled 430 patients who were randomized to receive either 12 mg of Zemprocitinib twice a day or placebo.

The primary objective was the proportion of patients achieving an ACR20 response after 24 weeks, while key secondary endpoints measured the percentage achieving ACR50 and DAS28 (CRP) ≤ 3.2.

Efficacy Findings

The results were compelling. The ACR20 response rates at Weeks 12 and 24 were 74.0% versus 29.9% and 79.1% versus 39.7% respectively (both P < 0.0001). Similarly, the ACR50 response rates showed a significant difference: 41.4% at Week 12 and 55.8% by Week 24 against 9.3% and 22.0% for placebo (P < 0.0001).

Moreover, the proportion of patients achieving DAS28 (CRP) ≤ 3.2 was also notable, with rates hitting 51.2% at Week 12 and 67.0% at Week 24, compared to the placebo group's 15.0% and 23.4% respectively (P < 0.0001).

Safety Profile

The safety of Zemprocitinib was generally favorable, with most treatment emergent adverse events (TEAEs) classified as mild to moderate in severity (Grade 1–2). Importantly, there was no notable discrepancy in severe adverse events when compared to the placebo group, and no new safety signals were identified. The safety profile aligned closely with prior studies, underpinning its viability as a treatment option.

Expert Insights

Professor Zeng emphasized the implications of these results, stating, "Rheumatoid arthritis significantly affects patients' quality of life. The strong efficacy shown here across various endpoints highlights the potential of Zemprocitinib to offer a meaningful treatment alternative for those who struggle with this condition."

Dr. Zhao-Kui (ZK) Wan, CEO of Lynk Pharmaceuticals, expressed his optimism regarding the findings, noting, "These are the first disclosed trial results in China for a selective JAK1 inhibitor in patients with moderate to severe rheumatoid arthritis who have not responded to previous biologic therapies. We believe this oral therapy stands to provide significant benefits to patients."

Gaobo Zhou, Chief Investment Officer of Simcere, which partners in the commercialization of Zemprocitinib, added, "The strong performance observed in this Phase III study reinforces Zemprocitinib's therapeutic potential, and we remain committed to advancing its development for rheumatoid arthritis."

About Zemprocitinib

Zemprocitinib (LNK01001) is a next-generation JAK1 inhibitor designed specifically for autoimmune and inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, and others. Its superior selectivity for JAK1 over earlier generation drugs opens the door for greater efficacy while minimizing off-target effects. This is vital for enhancing treatment options and patient outcomes.

Conclusion

Lynk Pharmaceuticals' announcement of these Phase III results underscores the growing potential for innovative therapies in the treatment landscape of rheumatoid arthritis. As the company plans to present these findings at an international scientific conference, the anticipation for Zemprocitinib continues to build, potentially revolutionizing treatment paradigms for this challenging condition.