Positive results have been reported from a phase 3 study of KIT-302 (Kitov Pharmaceuticals), a combination of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib and the calcium channel blocker (CCB) amlodipine besylate. The investigational medication was designed to treat OA pain along with hypertension, a common adverse effect of stand-alone OA pain drugs. The study results suggest that KIT-302 may have beneficial effects on renal function. Damage to renal function can be a serious adverse effect of NSAIDs.
Further analysis of data obtained in the phase 3 study, of which top line results were announced in December 2015, showed that celecoxib increased serum creatinine levels compared with placebo. In contrast, while amlodipine alone reduced serum creatinine (–2.55 mcmol/L), a greater reduction in plasma levels of creatinine was achieved in patients receiving KIT-302 (–3.22 mcmol/L), suggesting better renal function.
Additional data supporting the conclusion that KIT-302 may have a beneficial effect on renal function included measurements of peripheral edema, a known adverse effect of CCBs, such as amlodipine. Peripheral edema was reported in 15.6% of patients receiving amlodipine compared with 8.2% of patients receiving KIT-302. These data suggest that KIT-302 may protect against amlodipine’s potential to cause renal fluid retention, according to Kitov Pharmaceuticals.
The phase 3, double-blind, placebo-controlled trial protocol was designed to quantify the reduction in hypertension in patients receiving KIT-302. The study was conducted in the United Kingdom in four groups of 26 to 49 patients each, with a total of 152 patients participating in the trial. Each patient was treated for two weeks. Group 1 received KIT-302; group 2 received amlodipine besylate only; and group 3 received celecoxib only. Group 4 was treated with a double placebo.
The study’s primary objective was to show that a combination of the two components of KIT-302 (group 1) lowers daytime systolic blood pressure (SBP) by at least 50% of the reduction in blood pressure achieved in patients receiving amlodipine alone (group 2). The final results showed a mean reduction in daytime SBP of 8.8 mm Hg in the amlodipine group compared with a reduction of 10.6 mm Hg in the KIT-302 group (P = 0.001).
Source: Kitov Pharmaceuticals; June 24, 2016.