Kitov Pharma's combo arthritis drug clears Phase III with an FDA filing on deck

Israel's Kitov Pharmaceuticals ($KTOV) said its proprietary combination of two old drugs successfully treated osteoarthritis pain without spiking blood pressure in a Phase III trial, paving a path to FDA submission.

The drug, KIT-302, combines two now-generic Pfizer ($PFE) drugs, the pain treatment Celebrex and hypertension therapy Norvasc. Kitov enrolled a 152-patient trial to test how a combination of the two compounds, celecoxib and amlodipine besylate, fared against each agent on its own, finding that KIT-302 significantly reduced blood pressure compared with Norvasc alone, the company said.

That effect was enough to clear the Phase III trial's primary endpoint, Kitov said, and the company is now planning to meet with the FDA about its data with eyes on a second-half 2016 regulatory filing for KIT-302 and hopes of winning approval the following year.

Kitov's case for the generic combination is that Celebrex, among many so-called NSAID treatments for pain, carries the dangerous side effect of elevating blood pressure. Doctors often prescribe hypertension drugs in tandem, and Kitov believes its first-of-its-kind combination could crack a multibillion-dollar market by providing a single-pill alternative.

The results sent Kitov's shares up as much 50% on Tuesday morning.

Headquartered in Tel Aviv, Kitov raised $13 million in a Nasdaq IPO last month, maintaining its listing on the Israeli stock exchange after bringing in U.S. investors. Behind its lead asset, Kitov has a Phase III-ready combination of the generic NSAID naproxen with amlodipine besylate.

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