Ono Pharmaceutical is paying Kai Pharmaceuticals $13 million up front for Japanese development and commercialization rights to the latter’s lead candidate KAI-4169. It is in Phase II development as an intravenously administered treatment for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
The deal gives Ono Japanese rights to all indications for injectable formulations of KAI-4169. Kai will receive additional development, regulatory, and commercial milestones plus royalties on Ono’s sales of resulting products.
KAI-4169 is a peptide agonist of the human cell surface calcium-sensing receptor (CaSR). Positive data from a Phase I single ascending-dose study in healthy volunteers and end-stage renal disease patients with CKD-MBD following hemodialysis were reported in March. The results showed that KAI-4169 was safe and well tolerated and resulted in significant and sustained dose-dependent reductions in serum PTH levels.
KAI-4169 is also in preclinical development as a transdermal patch product for daily administration in the treatment of stage 3 and 4 CKD-MBD predialysis patients, ESRD (stage 5 kidney disease) patients receiving peritoneal dialysis, renal transplant patients with CKD-MBD, and primary hyperparathyroid patients who are ineligible to undergo parathyroidectomy.