Pivotal program uses new FDA-approvable endpoint
The Phase 3 PIONEER program includes two identical double-blind, placebo-controlled Phase 3 trials. Each is designed to evaluate the safety and efficacy of PYRIDORIN® (pyridoxamine dihydrochloride) at 300 mg twice a day compared to placebo in reducing the rate of renal disease progression in Type 2 diabetic patients.
PYR-311 is in the process of enrolling approximately 600 patients randomized in a 1:1 ratio to receive either Pyridorin or placebo. Patients are being enrolled who have baseline serum creatinine (SCr) levels of 1.3 to 3.0 mg/dL and protein/creatinine ratio (PCR) levels greater than 1200 mg/g. Patients must also be on an established and stable regimen of ACE inhibitors (ACEIs) or Angiotensin II Receptor Blockers (ARBs)—the standard of care treatments for diabetic nephropathy—for 6 months prior to randomization. About 150 centers are expected to participate worldwide, with the majority located in the U.S.
Importantly, this pivotal trial utilizes a new endpoint, as established under a Special Protocol Assessment (SPA) with the FDA. Primary efficacy endpoints are time to a 50% increase in SCr levels, or end stage renal disease (ESRD). Pyridorin has also received Fast Track designation from the FDA for this indication.
Details about study enrollment and patient eligibility, can be found at clinicaltrials.gov.