KAI Pharmaceuticals Announces Phase 1 Results of KAI-4169 for the Treatment of SHPT

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Clinical Testing in Patients with Kidney Disease to Commence this Quarter

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–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 the 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.

“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.”

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.

About KAI Pharmaceuticals

KAI is a drug discovery and development company with novel clinical-stage programs in cardiovascular disease, renal disease complications and pain. 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 core program, KAI-4169 for the treatment of secondary hyperparathyroidism in kidney disease patients, is in Phase 1 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. KAI is a registered trademark of KAI Pharmaceuticals.

Contacts

KAI Pharmaceuticals, Inc.
Kristine M. Ball, 650-244-1131
Chief Financial Officer
Fax: 650-244-1199
kball@kaipharma.com
or
Burns McClellan, for KAI Pharmaceuticals
Media:
Justin Jackson, 212-213-0006, ext. 327
jjackson@burnsmc.com
or
Investors:
Juliane Snowden, 212-213-0006, ext. 343
jsnowden@burnsmc.com