Kitov Pharma (KTOV) Announces Positive Results for Additional KIT-302 Pharmacokinetic BE Study

September 27, 2016 10:37 AM EDT
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Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV) announced today that its lead drug candidate KIT-302 has successfully completed an additional pharmacokinetic (PK) bioequivalence (BE) study and once more successfully met the U.S. Food and Drug Administration's (FDA) standards for establishing bioequivalence to the reference drugs. The current study evaluated a lower dosage (2.5 mg) of amlodipine than in Kitov's previous PK bioequivalence study for the KIT-302 product containing 10 mg of amlodipine, the results of which were announced by Kitov on May 10, 2016.

"We are pleased with the results of our additional pharmacokinetic BE study, which brings us closer towards submitting our New Drug Application to the FDA for KIT-302 as planned," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

The study compared the PK of Kitov's combination drug KIT-302 in a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5 mg of amlodipine, indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib capsules and 2.5 mg amlodipine tablets. These evaluations were conducted under both fed and fasted conditions. The results demonstrated that for both the Cmax (the maximum blood level achieved) and Area Under the Curve (the area under the concentration time curve for drug levels), the 90% confidence intervals for both the amlodipine and celecoxib components of KIT-302 were documented to be between 80% and 125% of the values obtained with the off-the-shelf drugs. With these study results, Kitov has again met the FDA standard for demonstrating BE under both fed and fasted conditions.

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