Kitov Pharma (TLV:KTOV) is looking to a Nasdaq IPO to fund the final steps in development of its osteoarthritis drug. The product, which is already deep into Phase III, is a combination of Pfizer's ($PFE) Celebrex and an antihypertensive drug, a mix Kitov thinks will enable it to avoid the black-box warnings that blight other treatments for osteoarthritis.
|Kitov Pharma CEO Isaac Israel|
Tel Aviv, Israel-based Kitov is aiming to raise $12.4 million (€11.6 million) through the IPO, $1.5 million of which will finance the wrapping up of a Phase III trial of KIT-302, the remix of Celebrex. The trial is assessing whether KIT-302 lives up to Kitov's expectation that it can treat pain related to osteoarthritis without raising the risk of heart attack and stroke. Kitov is aiming to show that KIT-302 can achieve at least 50% of the reduction in blood pressure as the antihypertensive in isolation, an outcome that would suggest the combination is offsetting some of the side effects of Celebrex.
Physicians already prescribe antihypertensives alongside non-steroidal anti-inflammatory drugs (NSAIDs) such as Celebrex, but Kitov is betting some would prefer to administer one dosage form that addresses both the osteoarthritis-related pain and blood pressure side effects. Kitov has worked on other drugs that follow the same NSAID-plus-antihypertensive model of KIT-302, but for now has decided to put all its money into its lead candidate. Around $2 million of the IPO cash is earmarked for manufacturing, pharmacokinetic and outlicensing activities for KIT-302.
This work will take in parallel to an ongoing Phase III study. The trial hit its initial enrollment goal of 150 people last month, setting it to potentially deliver the data for a NDA next year. Kitov hopes the number of people recruited to date will prove sufficient for the trial to hit its primary endpoint at an upcoming interim analysis by a third party. If the data fall short of this objective, Kitov will enroll as many patients as the independent data monitoring committee thinks are needed for the study to hit its primary endpoint.
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