Israel-based Kitov Pharmaceuticals Holdings Ltd said on Tuesday its lead drug met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA), reducing pain without increasing the risk of heart diseases in patients with a type of arthritis.
The company’s U.S.-listed plans to file its New Drug Application (NDA) for marketing approval with the FDA in the second half of 2016.
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The drug, KIT-302, was tested in the U.K. in 152 patients with osteoarthritis, a degenerative joint disease caused by aging joints, injury and obesity.
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The condition occurs most often in knees, hip, lower back and neck, small joints of fingers and bases of the thumb and big toe.
Most of the widely used painkillers contain severe health warnings that link them to heart-related risks.
Elevated blood pressure is a common side effect of stand-alone pain killers, which also increases the chances of heart problems.
But, KIT-302, which belongs to a class of painkillers called non-steroidal anti-inflammatory drugs (NSAID), is a combination pill that simultaneously treats joint pain and elevated levels of blood pressure.
The primary efficacy of the trial was to show that a combination of the two components of KIT-302, lowers daytime systolic blood pressure by at least 50 percent.
“We believe we would expect to receive marketing approval in 2017, ” stated Kitov CEO Isaac Israel.
“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. 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.”
Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.
