NEW YORK, NY / ACCESSWIRE / May 3, 2016 / Combining two existing generic drugs, a new, safer solution to osteoarthritis pain is found; Kitov's drug passed Phase III with stunning results;
Drug companies run the range of novel new therapies and creative use of older medicines. This latter category is exciting because FDA approval is easier - clinical trials have already been done and safety issues solved. But not all pharma firms travel this path successfully until Kitov Pharmaceuticals Holdings LTD (NASDAQ: KTOV), whose work treating a pervasive worldwide medical condition costing healthcare billions of dollars, found a way.
Kitov takes existing drugs and makes them work better together. Its first indication is osteoarthritis (NYSE:OA), or degenerative joint disease where cartilage of the hips, knees and spine breaks down and inflammation sets in, causing pain. The condition gradually worsens, and no cure exists. Over-the-counter pain relievers are the drug of choice, but they cause an increase in blood pressure which, in turn, can lead to cardiovascular disease (NYSE:CVD).
Ingeniously mixing celecoxib, a non-steroidal anti-inflammatory drug (NSAID) originally marketed by Pfizer Inc. (NYSE:PFE) as Celebrex until going generic in 2014, and amlodipine besylate, another Pfizer drug sold as Norvasc for lowering blood pressure until patent expiration in 2007, Kitov's lead compound, KIT-302, tackles pain and the unfortunate result of using NSAIDs for pain - hypertension. Nothing like it has been developed before.
Late last year, Kitov scored big when its drug hit a primary efficacy endpoint in Phase III in a trial designed to measure drops in blood pressure in those receiving KIT-302. Separated into four groups, 152 patients treated over two weeks received KIT-302, Norvasc alone, Celebrex alone, or placebo. Trial results were analyzed after 17 months, post-treatment, its goal to show Kitov's drug lowered daytime systolic blood pressure by half as compared to patients receiving only Norvasc.
It worked. Patients taking Norvasc - mean reduction in daytime blood pressure of 8.8 mm Hg (as recorded by blood pressure cuff); patients taking KIT-302 - mean reduction of same of 10.6 mm Hg, a statistically significant result and enough for FDA to entertain a new drug application, for which Kitov plans to submit this year with expected marketing approval in 2017.
There's more: further data drilling showed KIT-302's beneficial effect on blood pressure was not limited to daytime systolic measures, but to nighttime as well, enhancing the drug's power. Celebrex alone was shown to increase blood pressure, as research predicted. End result - Kitov has created a new, safe way to take NSAIDs, revolutionizing the management of OA pain with one pill.
Research is peppered with references correlating OA, NSAIDs and hypertension with risk of CVD. Advil, Motrin and Aleve (Tylenol is found not effective in battling OA pain) make the body retain fluid which decreases kidney function, which in turn causes blood pressure to rise, putting stress on the heart. One seminal study showed a telling link between NSAID use and CVD: where NSAIDs were taken, the result was a four-fold surge in opportunity of heart attack and stroke. Another study comprising 10,000 people with OA showed higher risk of CVD, often leading to death, no doubt due to NSAID use.
Given the widespread prevalence of OA - over 27 million people in the US alone with medical costs of $154 billion, half of which have hypertension - and the drawbacks of current treatment, pharma firms are clamoring for a piece of the market. Likewise, our overburdened healthcare system would embrace new, effective and safe methods to treat OA, considered the top cause of disability in the US and in the top ten throughout the rest of the world.
One inexpensive path would be to reassign existing medications to OA, which is what's been done with Eli Lilly and Company's (NYSE:LLY) Cymbalta, a popular anti-depression drug approved for OA pain in 2010. Same side effects apply: nausea, drowsiness, constipation and change in appetite. In 2014, FDA required that Cymbalta carry a black box warning, the agency's highest form of conveying risk, urging users to recognize suicidal thoughts. Further, fainting may occur in those taking blood pressure medicine, which constitutes a high percentage of aging people with OA.
Trials using monoclonal antibodies directed at blocking a nerve growth factor associated with OA pain have been fraught with misfortune. A clinical hold was issued from the FDA for this class of drugs after a large Phase III trial sponsored by Pfizer was halted in 2013 when its compound caused bone deterioration and actually accelerated OA. The trial has resumed after FDA lifted the ban, but there is no mention of changes to the drug to prevent prior adverse effects and, even if successful, doctors might be hesitant to prescribe it given its stigma.
Another large Phase III using a different monoclonal antibody in the same class was terminated several weeks ago by Johnson & Johnson (NYSE:JNJ). Although reason cited was a "strategic portfolio prioritization", the drug, in-licensed in 2008, was part of the company's 2015 list of future blockbusters with sales topping $1 billion annually, which stretches credibility that the decision was not made out of safety concerns.
Regardless of whether monoclonal antibodies work in OA without side effects, I doubt patients would choose a series of uncomfortable and inconvenient injections over a pill.
Kitov came public in November 2015 in a 1:1 combination of American Depository Shares and warrants, for gross proceeds of $13 million. Operating loss in fiscal 2015 was $4 million and depending whether research and development costs subside and operating expense remains steady, runway is limited. Kitov's Phase III was small relative to most, creating risk that larger populations taking the drug may show less efficacy or greater adverse effects. Patents are not yet issued so protection is a concern. Resources to develop new combination drugs may not be available without raising more money. Trading is thin, allowing for volatility.
For investors, Kitov embodies a rare ground floor opportunity to benefit from an exceptional drug that treats two diseases for the price of one, selling into multi-billion dollar markets, providing a solution to physicians hesitant to recommend NSAIDs due to heart effects, and lending significant cost savings to health care payors. KIT-302, if approved, is likely to be widely prescribed. In the future, new Kitov combination drugs would follow KIT-302's pattern of low development risk and efficient regulatory pathways, returning a quicker than usual return on investment.
About Small Cap Forecasting, Inc.
Sharon di Stefano has spent 20 years as an analyst, beginning her career at Smith Barney, Harris Upham & Co. specializing in medical devices, pharmaceuticals, healthcare information technology, and bio-pharmacology. Ms. di Stefano had also served as Senior Venture Officer for the Edison Innovation Fund, implemented through the New Jersey Economic Development Authority that provided funding for early-stage life sciences companies. Industry experience includes laboratory research for Johns Hopkins Hospital and the Department of Defense. Ms. di Stefano received a Master's of Science degree, in Business, from Johns Hopkins University in 1986, and a Bachelor of Arts from the University of Delaware in 1984 with a minor in biology.
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Jackie Rodriguez
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SOURCE: Small Cap Forecasting, Inc.
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