The company's U.S.-listed shares were up 26 percent at $4.50 in
premarket trading.
The drug, KIT-302, was tested in 152 patients with osteoarthritis
(OA), a degenerative joint disease caused by aging joints, injury
and obesity.
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.
Israel-based Kitov said its drug does not need to be labeled with
health warnings but will instead say it reduces the risk of
cardiovascular events.
Elevated blood pressure is a common side effect of stand-alone pain
killers, which also increases the chances of heart problems.
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.
There is no single medication to treat both osteoarthritis pain and
hypertension and thus, KIT-302, if approved, will be the only NSAID
for use in both conditions, Kitov Chief Medical Officer Paul Waymack
told Reuters.
Kitov, which debuted on the Nasdaq in November, uses U.S. drugmaker
Pfizer's FDA-approved drugs, celecoxib (Celebrex) for pain and
amlodipine besylate for hypertension.
Most pain medications, including celecoxib, had global sales of $2.7
billion in 2014, Kitov said.
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About 27 million Americans are suffering from osteoarthritis,
according to the Arthritis Foundation.
Data on Tuesday from the late-stage study showed that combination
KIT-302 significantly reduced blood pressure and pain, compared with
a placebo, and was also better than the two drugs given separately.
Kitov plans to apply for marketing of the drug in the second half of
2016, and expects to launch it in summer 2017 if approved, Kitov's
Chief Executive Isaac Israel told Reuters.
Israel, who is "highly confident" about the quality of data on the
drug, said "there are highly fewer chances that the FDA does not
approve KIT-302".
(Reporting by Rosmi Shaji in Bengaluru; Editing by Sriraj Kalluvila)
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