Kitov Pharmaceuticals 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, Consensi™, aims to treat osteoarthritis pain and hypertension simultaneously. Consensi™ achieved the primary efficacy endpoint in its Phase III clinical trial, and Kitov submitted a New Drug Application (NDA) in July 2017. The U.S. Food & Drug Administration (FDA) filed the NDA in September 2017, thereby accepting it for a full review. Under the Prescription Drug User Fee Act (PDUFA), on May 31, 2018, FDA approved Consensi™ for marketing in the U.S.A. Additional data from the Phase III clinical trial also suggested beneficial effects of Consensi™ on renal (kidney) function. As such, Kitov conducted a Phase III/IV clinical trial in the second half of 2017. The second trial’s top-line results, which were announced in October 2017, not only validated the top-line results of the Phase III trial, but also showed that Consensi™ improves renal function. The full clinical study report is expected to be completed in Q2/2018. (http://kitovpharma.investorroom.com/news-releases?item=64)
Kitov’s newest drug, NT-219, is being developed by its majority-held subsidiary TyrNovo. NT-219 is a first-in-class small molecule that targets IRS1/2 and STAT3 – two signal proteins that are part of an anti-cancer drug resistance mechanism. In various preclinical models where NT-219 was administered in combination with various oncology therapies, outstanding efﬁcacy in preventing acquired resistance and reversing tumor resistance was demonstrated.
By lowering development risk and cost through fast-track regulatory approval of novel therapeutics, Kitov plans to deliver a rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives.
Founded in 2010, Kitov became a public company in 2013 when its shares were first traded on the Tel Aviv Stock Exchange (TASE). Kitov successfully issued an IPO on NASDAQ in November 2015. The company currently trades on both stock exchanges.