KAI Pharmaceuticals Announces Phase 1 Results Of KAI-4169 For The Treatment Of Secondary Hyperparathyroidism (SHPT)

Main Category: Urology / Nephrology
Also Included In: Endocrinology
Article Date: 22 Jul 2010 - 2:00 PDT

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KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced the Company has completed enrollment in a Phase 1 study of KAI-4169, a novel pharmaceutical agent for the treatment of secondary hyperparathyroidism (SHPT), which is a frequent complication of end stage renal disease (ESRD). The Phase 1 study was a double-blind, randomized, placebo-controlled, rising single intravenous (IV) dose study to assess safety and tolerability of KAI-4169 in healthy male volunteers. Preliminary data from the study demonstrated KAI-4169 to be safe and well-tolerated and have confirmed the potency and activity of KAI-4169 by demonstrating dose-dependent reductions in parathyroid hormone and serum calcium levels. KAI plans to begin recruitment in a Phase 1b study in patients with ESRD and SHPT this quarter.

Steven James, President and CEO of KAI, commented, "We are pleased to have successfully demonstrated safety and proof of principle for KAI-4169 in this Phase 1 study. Clinical testing in hemodialysis patients with SHPT will begin shortly as we are on an aggressive timeline for bringing this much needed treatment to market."

About 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 and can lead to significant morbidity. In the U.S., there are roughly 350,000 and 8 million patients with ESRD and CKD, respectively.

Source:
KAI Pharmaceuticals

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