GenKyoTex S.A. Completes Enrollment Into Phase 2 Trial Of NOX1&4 Inhibitor GKT137831 In Diabetic Nephropathy
Safety Monitoring Board Recommends Trial Continues as Planned
Top-line data expected mid-2015
GENEVA & ARCHAMPS, France--(BUSINESS WIRE)--Genkyotex, the leading developer of selective NOX inhibitors, today announced the completion of patient enrollment into its Phase 2 trial of GKT137831 in diabetic nephropathy. In addition, the trial’s independent Safety Monitoring Board has conducted its first scheduled safety review and recommended that the trial should continue as planned.
“We are on track to report key data from our Phase II trial of GKT137831 in mid- 2015,” said Dr. Philippe Wiesel, Chief Medical Officer of Genkyotex. “I would like to thank the investigators and patients who have supported us in achieving rapid enrollment.”
GKT137831 is a first-in-class dual inhibitor of NOX1 and NOX4 enzymes. It leads a franchise of NOX1&4 inhibitors that also includes GKT901, a drug expected to enter clinical trials next year.
Genkyotex’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, representing major market opportunities. Added Dr Wiesel: “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 2 trial in diabetic nephropathy provides an important early opportunity for proof of concept in an area of significant unmet need.”
NOX1 and NOX4 have well-documented roles in the development of diabetic complications, amongst which diabetic kidney disease is a major cause of morbidity and mortality.
GKT137831 previously completed four Phase 1 studies including more than 100 healthy subjects. GKT137831 was well tolerated, with no safety signals and no dose-limiting toxicities identified.
About the Phase 2 trial with GKT137831
Genkyotex’s multicenter, placebo-controlled, double-blind, randomized, Phase 2 trial has enrolled 155 patients with diabetic nephropathy at sites in the US, Canada, Europe, and Australia. The primary endpoint of the study is the change from baseline in the urine albumin-to-creatinine ratio (UACR, a validated measure of efficacy in diabetic nephropathy). Secondary endpoints 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.
About Diabetic Nephropathy
Diabetic nephropathy is a chronic kidney disease that occurs as a complication of diabetes. It is the leading cause of end-stage renal disease, for which patients require dialysis or kidney transplant. According to GlobalData, the prevalence of nephropathy among diagnosed diabetic patients in the US, major EU markets, and Japan was approximately 14 million in 2012. Diabetic nephropathy therefore represents a major public health burden.
About Genkyotex
Genkyotex is unlocking the potential of NOX enzyme inhibition to discover and develop a pipeline of drugs for hard to treat chronic diseases. NOX enzymes oxidize proteins, activating multiple disease pathways. Our first-in-class NOX inhibitors block this process to achieve broad therapeutic benefit in a range of prevalent and orphan diseases.
Genkyotex was founded in 2006 by scientists from Switzerland, the USA and Japan, with backing from Geneva incubator Eclosion. Since 2011, expansion of the investor base, led by Edmond de Rothschild Investment Partners, with Eclosion2, Vesalius BioCapital and MP Healthcare Venture Management, has provided significant investment to Genkyotex. www.genkyotex.com
Contacts
Genkyotex*
Dr. Ursula Ney, CEO
Tel: +44 7900 898708
Email: ursula.ney@genkyotex.com
or
Dr. Daniel Elger, Chief Financial and Corporate Development Officer
Tel: + 44 7909 915068
Email: daniel.elger@genkyotex.com
or
Halsin Partners
Mike Sinclair
Tel: +44 20 7318 2955
Email: msinclair@halsin.com
*Attending and available at the Kidney Week congress in Philadelphia organized by the American Society of Nephrology.
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Top-line data expected mid-2015
GENEVA & ARCHAMPS, France--(BUSINESS WIRE)--Genkyotex, the leading developer of selective NOX inhibitors, today announced the completion of patient enrollment into its Phase 2 trial of GKT137831 in diabetic nephropathy. In addition, the trial’s independent Safety Monitoring Board has conducted its first scheduled safety review and recommended that the trial should continue as planned.
“We are on track to report key data from our Phase II trial of GKT137831 in mid- 2015,” said Dr. Philippe Wiesel, Chief Medical Officer of Genkyotex. “I would like to thank the investigators and patients who have supported us in achieving rapid enrollment.”
GKT137831 is a first-in-class dual inhibitor of NOX1 and NOX4 enzymes. It leads a franchise of NOX1&4 inhibitors that also includes GKT901, a drug expected to enter clinical trials next year.
Genkyotex’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, representing major market opportunities. Added Dr Wiesel: “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 2 trial in diabetic nephropathy provides an important early opportunity for proof of concept in an area of significant unmet need.”
NOX1 and NOX4 have well-documented roles in the development of diabetic complications, amongst which diabetic kidney disease is a major cause of morbidity and mortality.
GKT137831 previously completed four Phase 1 studies including more than 100 healthy subjects. GKT137831 was well tolerated, with no safety signals and no dose-limiting toxicities identified.
About the Phase 2 trial with GKT137831
Genkyotex’s multicenter, placebo-controlled, double-blind, randomized, Phase 2 trial has enrolled 155 patients with diabetic nephropathy at sites in the US, Canada, Europe, and Australia. The primary endpoint of the study is the change from baseline in the urine albumin-to-creatinine ratio (UACR, a validated measure of efficacy in diabetic nephropathy). Secondary endpoints 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.
About Diabetic Nephropathy
Diabetic nephropathy is a chronic kidney disease that occurs as a complication of diabetes. It is the leading cause of end-stage renal disease, for which patients require dialysis or kidney transplant. According to GlobalData, the prevalence of nephropathy among diagnosed diabetic patients in the US, major EU markets, and Japan was approximately 14 million in 2012. Diabetic nephropathy therefore represents a major public health burden.
About Genkyotex
Genkyotex is unlocking the potential of NOX enzyme inhibition to discover and develop a pipeline of drugs for hard to treat chronic diseases. NOX enzymes oxidize proteins, activating multiple disease pathways. Our first-in-class NOX inhibitors block this process to achieve broad therapeutic benefit in a range of prevalent and orphan diseases.
Genkyotex was founded in 2006 by scientists from Switzerland, the USA and Japan, with backing from Geneva incubator Eclosion. Since 2011, expansion of the investor base, led by Edmond de Rothschild Investment Partners, with Eclosion2, Vesalius BioCapital and MP Healthcare Venture Management, has provided significant investment to Genkyotex. www.genkyotex.com
Contacts
Genkyotex*
Dr. Ursula Ney, CEO
Tel: +44 7900 898708
Email: ursula.ney@genkyotex.com
or
Dr. Daniel Elger, Chief Financial and Corporate Development Officer
Tel: + 44 7909 915068
Email: daniel.elger@genkyotex.com
or
Halsin Partners
Mike Sinclair
Tel: +44 20 7318 2955
Email: msinclair@halsin.com
*Attending and available at the Kidney Week congress in Philadelphia organized by the American Society of Nephrology.
Help employers find you! Check out all the jobs and post your resume.