Chapel Hill, NC, November 13, 2014, Vascular Pharmaceuticals, Inc. announced today that it has initiated a Phase 2 clinical trial of VPI-2690B for the treatment of diabetic nephropathy. VPI-2690B is a first in class monoclonal antibody that binds to a unique molecular target within the αVß3 receptor. VPI-2690B was found to be safe and well tolerated in a Phase I combination single and multiple dose escalation study conducted in healthy volunteers.
“VPI-2690B represents an entirely novel approach to the treatment of diabetic nephropathy and pre-clinical evidence demonstrates that VPI-2690B may slow the development and progression of decline in kidney function without any evidence of detrimental side effects,” said David Clemmons, M.D., Founder and Chief Scientific Officer of Vascular Pharmaceuticals.
The Phase 2 randomized, double blind, placebo-controlled study will enroll approximately 300 patients with nephropathy due to type 1 or type 2 diabetes from multiple centers throughout the United States. Patients will receive a subcutaneous dose every two weeks over a 48-week period. The primary end point for the study is the change in albuminuria from baseline. The secondary end point is change in eGFR change from baseline.
“The initiation of this study is an important step for Vascular Pharmaceuticals and we are hopeful that VPI-2690B will provide an effective treatment for patients with nephropathy due to type 1 or type 2 diabetes,” said Richard Shea, President and Chief Executive Officer of Vascular Pharmaceuticals.
Additional details on this clinical study, including enrollment criteria, can be found at clinicaltrials.gov.
About Diabetic Nephropathy
Approximately 29.1 million people in the United States have diabetes1. Diabetic nephropathy is a serious complication of diabetes and the leading cause of chronic kidney disease. In the United States, diabetic nephropathy accounts for approximately 40% of the new cases of end stage renal disease (ESRD)2. There is no cure for diabetic nephropathy. Currently approved treatment options include only antihypertensive drugs that affect the renin-angiotensin-aldosterone system and have the ability to delay, but not stop, the progression of the disease. Treatment options for patients with severely limited kidney function include dialysis or kidney transplantation and are expensive and limited in availability.
1 National Diabetes Statistics Report, 2014.
2 American Diabetes Association.
About Vascular Pharmaceuticals
Vascular Pharmaceuticals, Inc. is a privately held biopharmaceutical company developing VPI-2690B for complications of diabetes such as diabetic nephropathy. The company was formed based on research conducted at the University of North Carolina School of Medicine and is the exclusive licensee of a set of patents providing comprehensive coverage of the VPI-2690B program. VPI-2690B targets the αVß3 integrin receptor which is involved in aberrant cellular signaling that occurs in the presence of high glucose and leads to damage to several key cell types involved in maintaining kidney filtration. Vascular Pharmaceuticals is headquartered in Research Triangle Park, NC.