NeuroMetrix reported positive trial data for its wireless transcutaneous electric nerve stimulation device for chemotherapy-induced peripheral neuropathy. (Image Credit: namtipStudio / Shutterstock.)

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.