Kitov Pharmaceuticals announced that the Phase 3 study for KIT-302 successfully met its primary efficacy endpoint. KIT-302 was more efficacious at reducing hypertension than amlodipine besylate.

The Phase 3 study was a double-blind, placebo-controlled clinical trial designed to quantify the decrease of hypertension in patients treated with KIT-302. The trial was conducted on 4 groups of patients over a 2-week period. Group 1 included patients treated with KIT-302; Group 2 with amlodipine monotherapy; Group 3 with celecoxib monotherapy; and Group 4 with double placebo. The efficacy endpoint was to show that KIT-302 (Group 1) reduces daytime systolic blood pressure by at least 50% of the reduction achieved in patients treated with amlodipine only (Group 2).

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Final results showed that patients treated with amlodipine monotherapy had a mean reduction in daytime systolic blood pressure of 8.8mm Hg compared to 10.6mm Hg in patients treated with KIT-302, achieving the study’s primary endpoint (P=0.001).

Kitov intends to file its New Drug Application (NDA) for KIT-302 to the Food and Drug Administration (FDA) for marketing approval in the second half of 2016.

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

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