Israel-based, biopharmaceutical company Kitov Pharmaceuticals has reported positive data following the successful completion of its Phase III trial of combination drug KIT-302 to improve renal function.
KIT-302 is a combination of the US Food and Drug Administration (FDA) approved drug celecoxib (Celebrex), which treats pain triggered by osteoarthritis, and another FDA-approved drug amlodipine besylate, which treats hypertension.
The double-blind, placebo-controlled Phase III trial was intended to quantify the decrease of hypertension in patients administered with KIT-302.
The trial included four groups of 26 to 49 patients each, with a total of 152 patients and was performed in the UK. Each patient was treated over duration of two weeks.
Group I was treated with KIT-302, group II was only treated with amlodipine besylate, while group III was only treated with celecoxib and group IV was treated with a double placebo.
The trial was primarily focused on demonstrating the capability of the combination of the two KIT-302 components, administered to Group One, in reducing daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved within patients in Group Two, who were only treated with amlodipine besylate.
The company noted that the final results have exhibited a greater rate of reduction in daytime systolic blood pressure after being treated with KIT-302.
Furthermore, analysis of the Phase III clinical trial data has also demonstrated the ability of the combination drug KIT-302 in reducing plasma levels of creatinine, thereby improving the renal function, which is affected by nonsteroidal anti-inflammatory drugs (NSAIDs).
Kitov chief medical officer Dr Paul Waymack said: "We are very pleased with the outcome of the renal function analysis.
"We believe it demonstrates that, in addition to addressing hypertension side effects caused by celecoxib, KIT-302 also addresses fluid retention resulting from amlodipine: a known side effect caused by calcium channel blockers."
According to Kitov CEO Isaac Israel, the company is planning to conduct another clinical trial for a scientific validation of the renal benefits rendered by KIT-302, along with submitting the new drug application (NDA) at the end of this year.