ABOUT KITOV


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, KIT-302, aims to treat osteoarthritis pain and hypertension simultaneously. KIT-302 achieved the primary efficacy endpoint for 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), the FDA has set a target date of May 31, 2018, to complete its review.

 

Kitov's newest drug, NT-219, which is developed by its majority-owned subsidiary, TyrNovo, is a first-in-class small molecule targeting IRS1/2 and STAT – 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.

 

KIT-302

Combination drug meets primary efficacy
endpoint in Phase III trial


Kitov’s KIT-302 is a combination drug that is indicated for the treatment of osteoarthritis pain and hypertension simultaneously. In December 2015, it was announced that the Phase III clinical trial for KIT-302 successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). Kitov submitted a New Drug Application (NDA) in July 2017. The FDA filed the NDA in September 2017, thereby accepting it for a full review, and under the Prescription Drug User Fee Act (PDUFA), has set a target date of May 31, 2018, to complete its review.

 

 

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NT-219

First-in-class small molecule designed
to overcome cancer drug resistance


NT-219 is an innovative, first-in-class small molecule designed to overcome cancer drug resistance. NT-219 targets two proteins involved in the anticancer drug resistance mechanism – IRS1/2 and STAT3. When administered in combination with various oncology therapies in various PDX models, NT-219 demonstrated outstanding efficacy in preventing acquired resistance and reversing tumor resistance. Preliminary synergistic effects were also observed in its combination with immune oncology agents such as Keytruda®.

 

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