KAI Pharmaceuticals Announces Promising Results of KAI-4169 Program for the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder

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SOUTH SAN FRANCISCO, CA, USA | June 7, 2011 | KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced clinical and preclinical data from its lead program, KAI-4169, at the Endocrine Society’s 93rd Annual Meeting (ENDO 2011) taking place in Boston, June 4-7, 2011. KAI-4169 is a novel pharmaceutical agent being developed for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD).  
Phase 1a pharmacokinetic and pharmacodynamic (PK/PD) data demonstrated a dose-dependent relationship between KAI-4169 exposure and reductions in serum parathyroid hormone (PTH) levels in healthy young males following single-dose administration. Further, the data validated an integrated PK/PD model that KAI believes may aid in the refinement of dose and regimen selection for future clinical studies.  
Preclinical data presented at ENDO 2011 confirmed the activity of KAI-4169 as a Calcium Sensing Receptor (CaSR) agonist. The CaSR inhibits secretion of PTH from the parathyroid gland and CaSR activation by KAI-4169 resulted in dose-dependent reduction in plasma PTH levels in preclinical models of CKD-MBD. In addition, chronic dosing of KAI-4169 in an in vivo model of CKD-MBD significantly decreased vascular calcification (a major clinical complication of CKD-MBD) and reduced parathyroid gland hyperplasia.  
“The data available for KAI-4169 are promising, and we are excited to present at ENDO 2011,” commented Steven James, President and CEO of KAI. “We are continuing to enroll patients in our Phase 2 study of KAI-4169 and look forward to announcing further progress in this program by the end of the year.”  
KAI Pharmaceuticals ENDO 2011 Presentations:  
Title: The PK/PD Relationship of a Novel Peptide, KAI-4169, Following Single-Dose Administration to Healthy Young Males  
Authors: J Shen, A Vick, K Pickthorn, S Huang, G Bell  
Date/Time: Saturday, June 4, 2011 – 1:30 pm  
Session Info: Poster Session: Clinical – Parathyroid Hormone & Parathyroid Hormone-Related Peptide I (1:30 PM-3:30 PM)  
Title: Preclinical PK and PD Relationship for KAI-4169, a Novel Peptide Agonist of the Calcium Sensing Receptor  
Authors: S Walter, A Vick, T Hunter, A Baruch, J Janes, S Alexander, D Mendel  
Date/Time: Saturday, June 4, 2011 – 1:30 pm  
Session Info: Poster Session: Basic – Bone, Calciotropic Hormones & Vitamin D (1:30 PM-3:30 PM)  
Title: KAI-4169, a Novel Peptide Agonist of the Calcium Sensing Receptor for the Treatment of Secondary Hyperparathyroidism  
Authors: A Baruch, D Maclean, K Yin, K Das, JE Tomlinson, E Sho, J Janes, S Alexander, S Walter, D Mendel, F Karim  
Date/Time: Sunday, June 5, 2011 – 1:30 pm  
Session Info: Poster Session: Translational – Bone, Calciotropic Hormones & Vitamin D (1:30 PM-3:30 PM)  
About CKD-MBD  
In the U.S., there are roughly 350,000 and eight million patients with end-stage renal disease (ESRD) and CKD, respectively. Bone disease often develops early in CKD and worsens as renal function declines and the disease progresses. Most ESRD patients on dialysis are affected by CKD-MBD, which can lead to significant morbidity and mortality, including bone pain and fractures, vascular calcification and cardiovascular events.  
About KAI Pharmaceuticals  
KAI is a clinical-stage, biopharmaceutical company with a lead peptide product candidate, KAI-4169, in development for the treatment of CKD-MBD. Building on promising, early stage clinical data, KAI has advanced KAI-4169 into a Phase 2 clinical study in ESRD patients on dialysis, which is expected to complete in the second half of 2011. In addition, preclinical research is being conducted on pre-hemodialysis applications of KAI-4169.  
KAI’s leadership team has a strong background and track record in successful product development and commercialization. The Company is backed by a leading syndicate of venture investors, having raised $63 million in Series A and B rounds. KAI is headquartered in South San Francisco, California, and can be found online at www.kaipharma.com.  
SOURCE: KAI Pharmaceuticals, Inc.