The US National Institutes of Health (NIH) has provided an $8.9m grant to University of Alabama at Birmingham (UAB) professor Victor Thannickal to fund a Phase ll trial investigating the role of NOX enzymes in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs.
The trial will involve Genkyotex’s lead product candidate GKT831, which previously showed its efficiency in reducing vascular remodelling and secondary right heart disease in preclinical models.
To be led by a consortium of leading academic institutions, including UAB, the trial aims to evaluate the safety and efficacy of oral GKT831 to treat patients with idiopathic pulmonary fibrosis (IPF).
The investigator-initiated trial will be a placebo-controlled, double-blind, randomised, parallel group study.
As part of the trial, a total of 60 IPF patients receiving standard of care therapies will be enrolled.
The patients will be allocated to receive a 24-week treatment of oral GKT831 or matching placebo.
The trial’s primary endpoint includes the change in plasma levels at the end of the 24-week treatment period of o,o’-dityrosine – an oxidized covalent modification of protein tyrosine residues that has been shown to be a marker of pulmonary oxidative stress and is significantly elevated in patients with interstitial lung disease.
Its key secondary endpoints are changes in six-minute walk distance, forced vital capacity and high-resolution computed tomography (CT).
The trial is expected to start enrolling patients during the first half of next year.
Genkyotex chief medical officer Dr Philippe Wiesel said: “There is a critical need for effective therapies that can safely delay or reverse disease progression in IPF patients and, based on its profile, we believe that GKT831 could become an important treatment option in this indication.”
The company is currently examining GKT831 in two separate Phase ll clinical trials to treat patients with liver and kidney fibrosis, respectively.