Full Press Release Details
Kitov Reports New Data Demonstrating
KIT-302 Has Beneficial Effects on Kidney Function
TEL-AVIV, Israel (PR Newswire)
June 24, 2016 -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company
focused on late-stage drug development, today announced newly available data from its successfully completed Phase III study of
KIT-302 suggest beneficial effects on kidney (renal) function. Damage to renal function is a serious side effect of NSAIDs.
The Company's combination drug, KIT-302, 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 U.S. Food and Drug Administration approved drugs, celecoxib (Celebrex ) for the
treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.
Further analysis of data obtained in the Phase III clinical
trial, whose top line results were announced in December 2015, showed that celecoxib increased serum creatinine compared to placebo;
impaired renal function is a major concern with nonsteroidal anti-inflammatory drugs (NSAIDs). In contrast, while amlodipine alone
reduced serum creatinine (-2.55 umol/L), a greater reduction in plasma levels of creatinine was achieved in patients in the KIT-302
arm (-3.22 umol/L), suggesting better renal function.
Additional data supporting the conclusion that KIT-302 is beneficial
to renal function were measurements of peripheral edema, a known side effect of calcium channel blockers, such as amlodipine. Peripheral
edema was reported in 15.6% of patients receiving amlodipine but in only 8.2% of patients receiving KIT-302. These data suggest
that KIT-302 protects against the widely recognized undesirable side effect of amlodipine in causing fluid retention by the kidneys.
Dr. Paul Waymack, Kitov's Chief Medical Officer, 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."
"Given the potential marketing advantages of these findings,
we intend to conduct a clinical trial designed to scientifically validate these beneficial renal effects in parallel with the New
Drug Application we plan to submit at the end of 2016," stated Chief Executive Officer Isaac Israel. The study may also provide
an explanation for the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was
higher than that observed with amlodipine alone."
About the KIT-302 Phase III Trial
The Phase III, double-blind, placebo-controlled trial protocol,
approved by the FDA through the Special Protocol Assessment (SPA) process, was designed to quantify the decrease of hypertension
in patients receiving KIT-302. The trial was performed in the U.K. in four groups of 26 to 49 patients each, with a total of 152
patients in the trial. Each patient was treated over a total period of two weeks. Group One was treated with KIT-302, a combination
of celecoxib and amlodipine besylate. Group Two was treated with amlodipine besylate only, one of the components of KIT-302. Group
Three was treated with celecoxib only, the other component of KIT-302. Group Four was treated with a double placebo.
The primary efficacy end-point of the trial was to show that
a combination of the two components of KIT-302, as demonstrated in Group One, lowers daytime systolic blood pressure by at least
50% of the reduction in blood pressure achieved in patients in Group Two, who were treated with amlodipine besylate only. The final
results showed 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 was successfully achieved with a p-value of 0.001.
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 pain and hypertension 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, the content of which is not part of this press release, visit http://www.kitovpharma.com
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outcome; the Company's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results
of any clinical trials; the introduction of competing products; the impact of any changes in regulation and legislation that could
affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize the Company's products;
the lack of sufficient funding to finance the clinical trials; the difficulty of predicting actions of the USA FDA; the regulatory
environment and changes in the health policies and regimes in the countries in which we operate; or changes in the global pharmaceutical
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affecting the Company is contained under the heading "Risk Factors" in Kitov Pharmaceuticals Holdings Ltd.'s Registration
Statement on Form F-1 filed with the SEC, which is available on the SEC's website, http://www.sec.gov.
Chief Financial Officer
LifeSci Advisors, LLC