French biopharmaceutical firm Genkyotex has secured US regulatory approval to conduct a Phase II clinical trial of GKT831 for the treatment of idiopathic pulmonary fibrosis (IPF).

GKT831 is an inhibitor of NADPH oxidase 1 (NOX1) and NOX4. It is being developed to treat fibrotic diseases, including primary biliary cholangitis (PBC), as well as type 1 diabetes and kidney disease (DKD).

The new Phase II trial forms part of a multi-year research programme on the role of NOX enzymes in IPF. This programme is supported by an $8.9m grant from the US National Institutes of Health (NIH).

GKT831’s safety and efficacy will be assessed during the 24-week, placebo-controlled, double-blind, randomised, parallel-group trial in a total of 60 subjects on standard of care therapies.

The study will involve a 400mg twice a day dose, which demonstrated statistically significant improvements in various efficacy endpoints in a previous Phase II trial in PBC patients.

The dose also showed a favourable safety profile in the PBC study.

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.

The primary endpoint of the latest trial will be the change in plasma levels of o,o’-dityrosine at 24 weeks. O,o’-dityrosine was found to be a marker of pulmonary oxidative stress.

Key secondary endpoints of the study include changes in six-minute walk distance, forced vital capacity, and CT imaging.

Genkyotex chief medical officer Dr Philippe Wiesel said: “The clear efficacy, excellent safety, and quality of life improvement achieved by GKT831 in our recently reported PBC trial suggest that GKT831 may provide important therapeutic benefits in patients with IPF.”

GKT831 showed an efficient decrease in vascular remodelling and secondary right heart disease during preclinical studies involving lung disease models.