December 15, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Tel Aviv, Israel-based Kitov Pharmaceuticals announced today that its Phase III clinical trial for KIT-302 for the treatment of hypertension met its primary efficacy endpoint.
The trial, a double-blind, placebo-controlled trial, indicated that KIT-302 was better at lowering hypertension than amlodipine besylate. KIT-302 is a combination drug that treats hypertension as well as osteoarthritis. Hypertension is a common side effect of many osteoarthritis drugs. KIT-302 is made up of celecoxib (Celebrex, manufactured by Pfizer Inc. ) and amlodipine besylate, for hypertension.
The Phase III trial studied four groups of 26 to 49 patients in the U.K. It had a total of 152 patients, who were treated over a two-week period. One group received KIT-302, another group received amlodipine besylate alone, and one was treated with Celebrix alone. A fourth control group received a double placebo.
“We are very pleased with the successful and final outcome of our pivotal Phase III trial and we look forward to meeting with the FDA in the near future to finalize plans for our NDA submission,” said Isaac Israel, Kitov’s chief executive officer, in a statement. “We believe we will be ready to submit the NDA for KIT-302 in the second half of 2016. Should the NDA meet with the FDA’s approval, we would expect to receive marketing approval in 2017.”
Kitov launched its initial public offering (IPO) in November 2015, and raised about $13 million on the NASDAQ.
Kitov has been on a steady rise since its IPO. Shares traded for $2.61 on Nov. 25, the day of the IPO, lagged slightly to $2.47 on Dec. 12, rose to $3.07 on Dec. 11 and are currently trading for $4.75.
The company is also developing KIT-301, which is Naproxen combined with an anti-hypertensive medication. Naproxen is also a non-steroidal anti-inflammatory drug (NSAID), which is marketed under various names, including Midol and Aleve.
Currently there are no combination drugs on the market that treat both osteoarthritis and hypertension together. If approved, KIT-302 would be the first. Kitov indicates that most pain medications, including Celebrex, have worldwide sales of about $2.7 billion as of 2014. In the U.S. alone there are about 27 million people diagnosed with osteoarthritis.
“KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers,” said Paul Waymack, Kitov’s chairman of the board and chief medical officer, in a statement. “There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”
