Genkyotex announced that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application allowing the initiation of a Phase 2 trial of the Company’s lead product candidate, GKT831, in patients with idiopathic pulmonary fibrosis (IPF). This will be the third Phase 2 clinical trial of GKT831 in a fibrotic disease, adding lung fibrosis to liver fibrosis and kidney fibrosis as potential clinical indications for this compound. GKT831 recently demonstrated clinical evidence of anti-fibrotic and anti-inflammatory activity in patients with primary biliary cholangitis (PBC), a fibrotic liver disease. The investigator-initiated Phase 2 trial will be a placebo-controlled, double-blind, randomized, parallel group study to evaluate the safety and efficacy of oral GKT831 in patients with IPF receiving standard of care therapies. A total of 60 patients will be allocated to a 24-week treatment with oral GKT831 or matching placebo. GKT831 will be dosed at 400mg twice a day, the dose which achieved statistically significant improvements in multiple efficacy endpoints and demonstrated an excellent safety profile in the recently completed Phase 2 trial in patients with primary biliary cholangitis (PBC), a fibrotic liver disease. The primary endpoint of the IPF trial will be the change in plasma levels, at the end of the 24-week treatment period, of o,o’-dityrosine, which is an oxidized covalent modification of protein tyrosine residues that has been shown to be a marker of pulmonary oxidative stress and is markedly elevated in patients with interstitial lung disease6. Key secondary endpoints include changes in 6-minute walk distance, forced vital capacity and high-resolution CT imaging.