KAI Pharmaceuticals enrolls patients in Phase 1b study of KAI-4169 for treatment of SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease (ESRD). The Phase 1b study is a double-blind, randomized, placebo-controlled, crossover study to assess the safety and tolerability of single ascending doses of KAI-4169 in ESRD patients with SHPT undergoing hemodialysis. The study also will assess the pharmacokinetics of KAI-4169 and its effect on parathyroid hormone (PTH) and serum calcium levels.

“The initiation of testing in patients is a critical step in the progress of our development program for KAI-4169. Mineral and bone disorders can be devastating to the health of ESRD patients with SHPT. KAI is committed to addressing this compelling medical need.”

A recently completed Phase 1 trial showed KAI-4169 to be safe and well-tolerated and confirmed the potency and activity of KAI-4169 by demonstrating dose-dependent reductions in PTH and serum calcium levels in healthy male subjects.

Steven James, President and CEO of KAI, commented, "The initiation of testing in patients is a critical step in the progress of our development program for KAI-4169. Mineral and bone disorders can be devastating to the health of ESRD patients with SHPT. KAI is committed to addressing this compelling medical need."