December 17, 2015 Tel Aviv, Israel – Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced more data from its successfully concluded Phase III trial for its lead drug candidate, KIT-302. Data showed that the favorable blood pressure effects of KIT-302 were present in all blood pressure variables measured in the study. This not only confirms the study’s top-line findings, but also reveals that using a combination drug for treating pain can improve patient health.
KIT-302 is a combination drug that simultaneously treats osteoarthritis (OA) pain and hypertension (HTN), which is a common side effect of stand-alone OA drugs. KIT-302 is comprised of two FDA-approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (amlodipine), a drug designed to treat HTN.
Kitov’s Phase III study successfully met the primary efficacy endpoint, which was based on the difference in daytime systolic blood pressure reduction between patients treated with amlodipine and those treated with amlodipine and celecoxib.
Upon further review of its Phase III clinical results, Kitov determined that the blood pressure reduction synergy seen with combining celecoxib and amlodipine was present not only in the study’s primary efficacy endpoint, but also in all other blood pressure variables. The beneficial effect of celecoxib on blood pressure was not present when the drug was administered alone, when it was shown to elevate daytime systolic blood pressure relative to a placebo.
“These new data show that KIT-302 may have a very significant impact on how nonsteroidal anti-inflammatory drugs (NSAIDs) are used in the future” Dr. J. Paul Waymack, Kitov’s Chairman of the Board and Chief Medical Officer, said. “As the largest consumed class of drugs on the market, NSAIDs are generally a better chronic pain reduction alternative than narcotics. However, NSAIDs still carry a black-box warning in its labeling from the FDA due to their side effects, which include elevating blood pressure and increasing the risk of heart attack and stroke. By combining a widely used NSAID with amlodipine, KIT-302, the only once-a-day calcium channel blocker, actually reduces all blood pressure measures, and therefore, may offer a new, safer choice for doctors and their patients. Moreover, we believe the medical community will take great interest in this study’s findings and its implications for pain management and hypertension.”
The blood pressure reduction synergy was also seen for daytime diastolic blood pressure, nighttime systolic blood pressure, and nighttime diastolic blood pressure measurements. In other words, the synergy in blood pressure reduction demonstrated by KIT-302’s two components was present at all times of day and with both blood pressure measures. Although celecoxib, when combined with amlodipine, appears to have a synergistic effect and lowers blood pressure, it lacks this effect when administered by itself.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s pipeline currently features two combination drugs intended to treat osteoarthritis (OA) pain and hypertension (HTN) simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. Lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information, visit www.kitovpharma.com.