Lynk Pharmaceuticals has reported that the Phase II study of LNK01001 for rheumatoid arthritis (RA) treatment demonstrated statistically significant differences in efficacy against placebo in primary and key secondary efficacy endpoints.
The double-blind, randomised, placebo-controlled trial also showed good safety and tolerability.
It assessed the efficacy and safety of LNK01001 in patients with moderately to severely active RA.
These patients did not have an adequate response or were intolerant to conventional synthetic disease-modifying anti-rheumatic drugs.
A total of 156 subjects were part of the trial, which was led by Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences Department of Rheumatology and Immunology director Professor Xiaofeng Zeng.
These subjects were randomised into LNK01001 high-dose, low-dose, and placebo groups at a ratio of 1:1:1. The ACR20 response at week 12 is the trial’s primary endpoint.
Both low and high-dose groups of LNK01001 in the study were found to have surpassed all projected primary and key secondary endpoints at week 12. This demonstrated significant differences in efficacy compared with placebo.
Furthermore, it was observed that ACR20 rates of both low and high-dose groups reached more than 90% at week 24.
The study drug’s overall safety and tolerability were also found to be very good.
Lynk Pharmaceuticals chief development officer Dr Henry Wu said: “We are very encouraged by the results of our Phase II study. It showed that LNK01001 had significant therapeutic effects and a high level of safety in the treatment of patients with rheumatoid arthritis.
“The company has submitted EOP2/Pre-Phase III meeting request to CDE. We look forward to communicating with the regulatory authorities about the key aspects of the study.”
Lynk is actively seeking a partner for developing LNK01001 in markets worldwide.