Genkyotex, a biopharmaceutical company and the leader in NOX therapies, announced today that it has begun enrolling patients into the Company’s Phase 2 clinical trial of GKT831, its NOX1 and NOX4 enzymes inhibitor, in primary biliary cholangitis (PBC). Enrollment initiation at the first investigational center in the U.S. took place following regulatory clearance by the U.S. Food & Drug Administration and local Institutional Review Board. Dosing of the first patient is expected shortly.
Genkyotex is currently working on the activation of a large network of investigational centers participating in this global trial. In total, over 50 centers are expected to be activated in the United States, Canada and several European countries. Interim top-line results from the Phase 2 clinical trial are anticipated in the first half of 2018, and full results are expected in the second half of 2018.
“We are pleased to initiate patient recruitment for this promising clinical trial,” said Philippe Wiesel, MD, Executive Vice President and Chief Medical Officer of Genkyotex. “Alleviating progressive liver injury and fibrosis is an important therapeutic objective in patients with active PBC. We are grateful to the global network of experienced investigators who will participate in this important Phase 2 clinical study. We are now focused on delivering trial results over the next 18 months."
The Phase 2 clinical trial is a 24-week, double-blind, placebo controlled, multi-center trial evaluating the safety and efficacy of GKT831 in patients with PBC and inadequate response to ursodeoxycholic acid. A total of 102 PBC patients will be enrolled in this international study and allocated to placebo or one of two doses of GKT831 (400mg once a day or 400mg twice a day). The primary objective of the trial will be to demonstrate therapeutic activity through a reduction of gamma glutamyl transpeptidade, a marker of liver injury, which also reflects oxidative stress. Secondary efficacy endpoints include markers of liver inflammation and injury (CK-18, hs-CRP, ALT), non-invasive markers of liver fibrosis (Enhanced Liver Fibrosis score, transient elastography and circulating collagen fragments).
In addition, the trial will evaluate the effect of GKT831 on bile acid metabolism, itching, autoimmunity, and quality of life. Moreover, the trial will characterize the clinical safety profile and pharmacokinetics of GKT831 in this patient population. An interim analysis will be performed once 90 patients have completed their week 6 visit.