KIT-302 Successfully Meets U.S. Food and Drug Administration Bioequivalence Standards for 2.5 mg Amlodipine Dose
TEL AVIV, Israel, September 27, 2016 /PRNewswire/ --
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, 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.
About KIT-302
KIT-302 is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration within the coming months.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.
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. By lowering development risk and cost through fast-track regulatory approval of novel late-stage 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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Contact:
Simcha Rock
Chief Financial Officer
+972-3-9333121 ext. #105
simcha@kitovpharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
+1-646-597-6989
bob@LifeSciAdvisors.com
