October 21, 2015, Tel Aviv, Israel – Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today that it has completed recruitment of the initial 150 patients in its Phase III clinical trial for KIT-302. KIT-302 is Kitov’s combination drug designed to treat osteoarthritis (OA) pain and hypertension (HTN) simultaneously.
Upon completion of the treatment of these 150 patients, the trial data will be disclosed to an external, independent data monitoring committee (DMC). After analyzing the data’s standard deviations, the DMC will determine whether additional patients are to be recruited in order to demonstrate statistical validity, and to meet the trial’s primary end-point (interim results).
If more patients are required, the DMC will determine the number of such additional patients. The Committee’s analysis and publication of the interim results are expected to take up to eight weeks. Should the Committee recommend treatment of up to 200 additional patients, the Company will continue recruiting patients until reaching statistical validity and achievement of the trial’s primary end-point.
In accordance with the written recommendation of the FDA in its Special Protocol Assessment (SPA) response, there will be no statistical penalty resulting from the Committee’s analysis of the data following the trial’s initial stage.
KIT-302 combines a drug that treats pain and one that lowers blood pressure. The trial’s interim results, as agreed in writing with the FDA, is to demonstrate that the blood pressure reduction observed in an arm treated with KIT-302 is at least 50% of the blood pressure reduction observed in an arm treated only with the blood pressure drug.
“Completion of the recruitment of the initial 150 patients in the clinical trial is an important milestone in Kitov Pharmaceutical’s business development, and is additional evidence of the capabilities of the clinical development team, led by Dr. J. Paul Waymack,” Isaac Israel, CEO of Kitov, said. “We are anxiously awaiting the interim results, and are preparing for the continuation of our work plan in anticipation of submitting a New Drug Application (NDA) for our lead drug in 2016.”
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.