KAI Pharmaceuticals Announces Initiation of Phase 1b Study of KAI-4169 for the Treatment of Secondary Hyperparathyroidism

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- 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.

About KAI Pharmaceuticals

KAI is a drug discovery and development company with novel clinical-stage programs in cardiovascular disease and renal disease complications. KAI’s lead product candidate, KAI-9803, recently completed enrollment in a Phase 2b study (PROTECTION AMI) designed to assess the effect of KAI-9803 on reducing myocardial injury in heart attack patients. The Company has an exclusive agreement with Bristol-Myers Squibb (BMS) for the global development and commercialization of KAI-9803. KAI’s second program, KAI-4169 for the treatment of secondary hyperparathyroidism in kidney disease patients, is in Phase 1b testing.

KAI is the leader in the selective modulation of intracellular protein:protein interactions and delivery of peptides into the cell. This approach has broad potential and has been validated clinically. The Company has applied its core expertise to discover highly potent and selective inhibitors and activators for protein kinase C (PKC) isozymes. KAI is based in South San Francisco, California, and can be found online at www.kaipharma.com.

KAI is a registered trademark of KAI Pharmaceuticals.


KAI Pharmaceuticals, Inc.
Kristine M. Ball, 650-244-1131
Chief Financial Officer
Fax: 650-244-1199
[email protected]
Burns McClellan, for KAI Pharmaceuticals
Justin Jackson, 212-213-0006, ext. 327
[email protected]
Juliane Snowden, 212-213-0006, ext. 343
[email protected]

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