Phase III trial of KIT 302 (celecoxib + amlodipine) meets primary endpoint in pain relief in osteoarthritis- Kitov Pharmaceuticals

Kitov Pharmaceuticals has announced that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT 302 (celecoxib + amlodipine) successfully met the primary efficacy endpoint of the trial for pain relief in osteoarthritis, with hypertension reduction. The primary efficacy end-point of the trial was to show that a combination of the two components of KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only.

The trial results also demonstrated that the number of 152 patients treated was found to be adequate to provide statistical validity and therefore, the results are final. These final results show that in patients treated with amlodipine besylate only, there was a mean reduction in daytime systolic blood pressure of 8.8 mm Hg. In patients treated with KIT-302, there was a mean reduction in daytime systolic blood pressure of 10.6 mm Hg. Therefore, the primary efficacy endpoint of the study has been successfully achieved. Kitov plans to file its New Drug Application (NDA) for marketing approval of KIT-302 with the FDA in the second half of 2016.

Comment: Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, are non-steroidal anti-inflammatory drugs which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.