Promising results from KAI-4169 program for CKD-MBD presented at ENDO 2011

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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).

“The data available for KAI-4169 are promising, and we are excited to present at ENDO 2011”

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."

Source KAI Pharmaceuticals

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