TEL AVIV, Israel, October 26, 2017 /PRNewswire/ --
Results Validate Primary Efficacy Endpoint Achieved in Previous Successfully Completed Phase III Clinical Trial
KIT-302 Reduces Creatinine Levels Indicating Improved Renal Function, Compared to Negative Effects of other NSAIDs
Company Recently Submitted, and FDA Accepted for Filing, NDA for KIT-302 for Simultaneous Treatment of Osteoarthritis Pain and Hypertension
Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that its randomized double-blind, placebo-controlled renal function clinical trial for its lead drug candidate, KIT-302, successfully met its primary efficacy endpoint. Data from the trial demonstrated that KIT-302 lowered systolic blood pressure a comparable amount to the widely used antihypertension drug, amlodipine besylate, thus meeting the trial's primary efficacy endpoint of achieving at least 50% of the amlodipine reduction (p=0.019).
KIT-302, a combination drug, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®). The renal function study enrolled 104 patients randomized to three treatment groups: KIT-302, amlodipine besylate, and placebo. The primary efficacy endpoint of the trial was to show that 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. Secondary endpoints included various parameters of renal function.
The study also demonstrated that treatment with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.
When comparing the effect of KIT-302 to amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment arm. Both this creatinine measure and the edema measure were statistically insignificant.
Kitov submitted its New Drug Application (NDA) for marketing approval of KIT-302 to the U.S. Food and Drug Administration (FDA) in July 2017, and in September 2017, FDA filed the NDA, thereby granting a full review. Although the renal clinical trial was not required as part of the initial KIT-302 NDA submission, the Company anticipates completion and submission of the report to FDA by January 2018.
"We are very pleased with the results of our renal function clinical trial and look forward to submitting the related clinical study report to FDA. Although FDA has publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor and angiotensin receptor blocker classes, this study once again demonstrated that our combination lacks the toxicities of these other classes and combinations. This makes our combination uniquely suited for the millions of Americans with both osteoarthritis and hypertension. The reduction of creatinine levels by KIT-302, indicating improved renal function, as compared to the negative effects on renal function of other NSAIDs, further demonstrates the value of KIT-302," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ: KTOV, TASE: KTOV) is an innovative biopharmaceutical drug development company. 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 flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. Kitov's newest drug, NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
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