Addressing an unmet medical need to slow disease progression
At NephroGenex, we are committed to developing a more effective treatment for diabetic kidney disease—a critical global health issue. We are now in a Phase 3 study with PYRIDORIN® (pyridoxamine dihydrochloride), a novel acting compound to reduce the rate of disease progression in patients with diabetic nephropathy (DN) due to type 2 diabetes.
Currently available treatments for diabetic nephropathy are effective but a significant residual risk remains
Despite the availability of two classes of approved treatments for diabetic nephropathy (angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), diabetic nephropathy remains the most common cause of end stage renal disease. There is a significant unmet medical need for new treatments that can slow or stabilize the progression of diabetic nephropathy.
Therapy targets an underlying cause of the disease to improve outcomes
Unlike any currently approved therapies, Pyridorin slows down the formation of advanced glycation end products (AGEs) that have been implicated in the development of diabetic nephropathy.
A variety of completed preclinical studies in animal models of diabetes demonstrate that treatment with Pyridorin improves kidney histology and slows the progression of diabetic nephropathy.
Phase 2 data from over 650 subjects has enabled us to identify the type of patients that may demonstrate benefit from Pyridorin in a Phase 3 trial—type 2 diabetic patients with advanced kidney disease (serum creatinine >1.3mg/dL and <3.0mg/dL) who have a significant amount of protein in their urine (PCR >1200mg/g). Based on safety, efficacy and tolerability profile from the completed Phase 2 studies, we believe Pyridorin has the potential to address an important unmet need in type 2 diabetic patients with advanced kidney disease.
Our Phase 3 trial PYR-311, the first of two identical trials in our PIONEER program, is evaluating the safety and efficacy of Pyridorin to reduce disease progression in this patient population (see Clinical Trials). The design of the trial has been agreed with the FDA under a Special Protocol Assessment and Pyridorin has been granted a Fast Track designation by the FDA. For more information about our pivotal Phase 3 Pyridorin trial, see clinicaltrials.gov.