Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.

The Phase 3 study was a double-blind, placebo-controlled trial designed to quantify the decrease of hypertension in patients receiving KIT-302. A total of 152 patients were divided into four groups: Group 1 received KIT-302, Group 2 received amlodipine besylate only, Group 3 received celecoxib only, and Group 4 received double placebo. The primary efficacy endpoint was to demonstrate that the combination therapy of KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine alone. 

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Data presented in December 2015 showed that the study met its primary endpoint, showing that treatment with KIT-302 achieved a mean reduction in daytime systolic blood pressure of 10.6 mmHg vs. 8.8 mmHg for amlodipine alone (P=0.001). New findings from further analysis of the data showed that treatment with celecoxib alone increased serum creatinine while treatment with amlodipine alone and KIT-302 reduced it. A greater reduction in creatinine plasma levels was achieved in patients treated with KIT-302 (-3.22 umol/L) compared to patients treated with amlodipine only (-2.55 umol/L), suggesting better renal function. Measurements of peripheral edema were also assessed to evaluate the effect on renal function. Results supported the conclusion that KIT-302 is beneficial to the kidneys, showing that 8.2% in the KIT-302 arm reported peripheral edema vs. 15.6% in the amlodipine only arm.

KIT-302 is a combination drug product consisting of amlodipine besylate, a dihydropyridine calcium channel blocker, and celecoxib (Celebrex; Pfizer), a COX-2 inhibitor.

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