April 17, 2013 -- The use of statins to control cholesterol levels has a growing body of evidence supporting a broad range of potential side effects that may outweigh the benefits of the drugs, particularly in specific demographics. The University of Massachusetts discovered that postmenopausal women taking statins, such as blockbusters drugs like Pfizer Inc.’s (NYSE: PFE) Lipitor stood a increased risk of developing a type 2 diabetes side effect. Simply, that’s a large group of women, considering that the American Heart Association has said that half the women over age 40 will show clinical levels of the effects of atherosclerosis, or thickening of arterial walls due to plaque buildup.
Separate research on leading cholesterol busters in high doses, like AstraZeneca plc’s (NYSE: AZN) Crestor or Merck & Co.’s (NYSE: MRK) Zocor, has detailed substantial risks related to kidney failure or injury, elevated blood sugar levels, liver damage and more. In fact, research through the ASTEROID and SATURN studies has put forth not only questions of the effectiveness of statins, but suggested that statins may have a negative effect overall as discussed in a research report by Crystal Research Associates, LLC on AtheroNova Inc. (OTCQB: AHRO).
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As is typical, big pharma is looking to create reformulations to improve the efficacy and safety profiles of their blockbuster drugs as well as bolster their intellectual property portfolio to shelter the company from generics. Such is the case with Merck’s IMPROVE-IT study, evaluating Vytorin (a combination of its Zetia and Zocor drugs) with Zocor alone to reduce heart attacks and strokes in high-cholesterol patients.
This doesn’t appear to be the right path. It’s time to build a better cholesterol mousetrap and shift focus away reductions in enzyme production in the liver to combat LDL cholesterol. AtheroNova is initiating a Phase I clinical trial for their flagship compound, AHRO-001, as a new therapeutic that demonstrates delipidization, the dissolving of plaque within arterial walls and safe removal through the metabolic process.
A synthesis of a naturally occurring bile salt, AHRO-001 has shown in laboratory studies to provide a therapeutic benefit while being well tolerated, even in high doses. The drug is in the same classification as Ursodiol, the only drug with FDA approval as a treatment for primary biliary cirrhosis, perhaps giving it a competitive edge as it maneuvers down the regulatory pathway.
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The possible implications of a new, disruptive cholesterol-fighting drug are obviously enormous. While many big companies like Merck continue to pursue the PCSK9-inhibitor route to block LDL cholesterol production, AtheroNova is taking a different approach…one that could substantially change the landscape of atherosclerosis and its deadly effects. If Merck’s study fails to provide statistically significant data on the reduction of occurrence rates of heart attacks, strokes and other cardiovascular events related to cholesterol, one has to wonder if the FDA will approve another drug that can only reduce LDL cholesterol levels. It could also derail the efforts of other major pharma, causing them to re-think the approach and possibly start looking in different directions.
At that point, AtheroNova should be uniquely poised to attract big pharma with their accumulation of clinical data on AHRO-001.