SOUTH SAN FRANCISCO, Calif.— KAI Pharmaceuticals Inc. has started 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).
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 greater-than or equal to 30 percent reduction in PTH from baseline, the proportion of subjects with PTH less-than or equal to 300 pg/mL and the mean change from baseline in serum calcium and phosphorus.
"We are proud of the momentum and continued progress of KAI-4169, our lead program," said Steven James, president and CEO of KAI. “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."
CKD-MBD often develops early in CKD and worsens as renal function declines and the disease progresses. Most ESRD patients on hemodialysis are affected by CKD-MBD, which can lead to significant morbidity and mortality, including bone pain and fractures, vascular calcification and cardiovascular events.
Previous Phase 2 data have demonstrated that KAI-4169 was effective in the treatment of CKD-MBD and resulted in sustained reductions in PTH, calcium and FGF-23. The data also demonstrated that KAI-4169 was very well-tolerated. No subjects discontinued due to adverse events, and the incidence of gastrointestinal adverse events was similar in the KAI-4169 and placebo treatment groups.
