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.

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."

About Secondary Hyperparathyroidism (SHPT)

Secondary hyperparathyroidism develops early in chronic kidney disease (CKD) and worsens as renal function declines and progresses to end-stage renal disease. SHPT, which affects the vast majority of patients with ESRD, is associated with bone disease (high-turnover renal osteodystrophy) and cardiovascular disease (vascular calcification) and can lead to significant morbidity. In the U.S., there are roughly 350,000 and eight million patients with ESRD and CKD, respectively.

Source:
KAI Pharmaceuticals