KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced initiation of patient enrollment in the second Phase 2 study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD) in hemodialysis patients with secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease (ESRD).
The single-arm, open-label, multicenter, dose-titration study is designed to evaluate the effect of three times weekly intravenous bolus administration of KAI-4169 over a 12-week treatment period as assessed by percent change in parathyroid hormone (PTH) from baseline at the end of treatment. Secondary endpoints include proportion of subjects with â‰¥ 30% reduction in PTH from baseline, the proportion of subjects with PTH â‰¤ 300 pg/mL and the mean change from baseline in serum calcium and phosphorus.
Steven James, President and CEO of KAI, commented, "We are proud of the momentum and continued progress of KAI-4169, our lead program. We recently reported results of the first Phase 2 study of KAI-4169 at the annual meeting of the American Society of Nephrology in a late breaker poster presentation. We believe KAI-4169 may lead to greatly improved care for patients, and we look forward to reporting continued positive results and progress of our program."