Genkyotex closes patient enrolment in GKT137831 Phase II trial for diabetic nephropathy

13th November 2014 (Last Updated November 13th, 2014 18:30)

Swiss developer of selective NOX inhibitors Genkyotex has completed patient enrolment in its Phase II trial of GKT137831 to treat patients with diabetic nephropathy.

Swiss developer of selective NOX inhibitors Genkyotex has completed patient enrolment in its Phase II trial of GKT137831 to treat patients with diabetic nephropathy.

Additionally, the trial's independent Safety Monitoring Board has also conducted its first scheduled safety review and recommended that the trial should continue as planned.

Genkyotex chief medical officer Dr Philippe Wiesel said: "We are on track to report key data from our Phase II trial of GKT137831 in mid- 2015."

GKT137831 is a first-in-class dual inhibitor of NOX1 and NOX4 enzymes, and leads a franchise of NOX1&4 inhibitors that also includes GKT901, a drug expected to enter clinical trials in 2015.

"A total of 155 patients with diabetic nephropathy at sites in the US, Canada, Europe and Australia were enrolled in the multicenter, placebo-controlled, double-blind, randomised Phase II trial."

A total of 155 patients with diabetic nephropathy at sites in the US, Canada, Europe and Australia were enrolled in the multicentre, placebo-controlled, double-blind, randomised Phase II trial.

The trial's primary endpoint is the change from baseline in the urine albumin-to-creatinine ratio (UACR), a validated measure of efficacy in diabetic nephropathy.

The secondary endpoints of the trial include changes in markers of insulin resistance, pancreatic beta cell and adipose tissue dysfunction, and vascular inflammation, as well as predictive markers of progression to end-stage renal disease.

Dr Wiesel added: "Targeting NOX1 and NOX4 is a very promising and distinctive new therapeutic approach, and we intend to explore how this could benefit patients with a variety of fibrotic disorders.

"Our phase II trial in diabetic nephropathy provides an important early opportunity for proof of concept in an area of significant unmet need."

The company's NOX1&4 inhibitors have shown potential in a range of difficult-to-treat fibrotic and inflammatory conditions of the kidney, liver, lung and skin.

They have well-documented roles in the development of diabetic complications, among which diabetic kidney disease is a major cause of morbidity and mortality.

The company has already completed four Phase I trials of GKT137831 which including more than 100 healthy subjects, which showed that the drug was well tolerated, with no safety signals and no dose-limiting toxicities identified.