Everyone knows to call a plumber when the kitchen sink plugs up, but preventing our own arteries from doing the same is a bit more of a mystery. Over time, our arties accumulate fatty materials like cholesterol on their walls, eventually leading to a chronic disease called atherosclerosis that slowly progresses and accumulates over time. Eventually, the plaque buildup can rupture and stop blood flow, causing adverse events like heart attacks.
Clinical manifestations of atherosclerosis, including coronary artery disease, cerebrovascular disease and peripheral arterial disease, will occur in 2 of 3 men and 1 in 2 women after the age of 40, according to a 2008 report from the American Heart Association. Meanwhile, nearly 60% of deaths in the United States as a whole are due to cardiovascular disease, with subclinical atherosclerosis being a latent precursor to the ultimate clinical causes of death.
The best solution drug companies have come up with so far to treat atherosclerosis is the inhibition of an enzyme in the body that’s responsible for producing cholesterol in the liver. Doing this lowers cholesterol levels and, presumably, reduces plaque buildup on arterial walls over time. These drugs, known as statins, have generated billions of dollars for their makers, with Pfizer Inc.’s (PFE) Lipitor becoming the best selling drug of all time.
Statins Seem to Be Losing their Shine
While Pfizer’s (PFE) Lipitor, Merck & Co., Inc.’s (MRK) Zocor, and AstraZeneca plc’s (AZN) Crestor have generated billions of dollars in sales, statins have many drawbacks in both safety and efficacy that make them a less than ideal solution to treat and prevent atherosclerosis. Common side effects associated with taking statins include raised liver enzymes, muscle problems and myalgia, as well as gastrointestinal symptoms and rare cases of other disorders.
These problems would be worth the cost if statins were effective, but there’s mounting evidence to the contrary, particularly in high-risk primary prevention settings where the class of drugs is often prescribed. For instance, one 2010 meta-study of this patient population analyzed 11 randomized controlled trials involving 65,229 participants without finding evidence suggesting statin therapy improved all-cause mortality.
But, other studies have come up with even more troubling results. A recent 2012 study looked at the effects of statins on coronary artery plaque – the hallmark of atherosclerosis – in 6,673 patients and found that statin use was associated with an increase prevalence and extent of coronary plaques possessing calcium. These results suggest that statin use may actually be detrimental and the longitudinal effect of statins should be investigated further.
Shifting Focus Away from Cholesterol
In 1984, Nobel Award winners Michael Brown and Joseph Goldstein famously said that, “the more LDL there is in the blood, the more rapidly atherosclerosis develops.” The statement became the framework for the rapid development and growth of statins, but many recent studies call this basic underlying premise into question. Many of these studies have shown that the degree of atherosclerosis and its growth are independent of LDL concentrations.
For instance, a 2005 article in the Journal of American Physicians and Surgeons found that the concept that LDL is “bad cholesterol” is a “simplistic and scientifically untenable hypothesis.” Among other things, the article cited a study where researchers found atherosclerosis regression in patients with the greatest regression in CRP levels, but not in those with the greatest reduction in LDL cholesterol levels. These studies and others seem to confirm that LDL cholesterol may not be a valid target, at least on its own, for atherosclerotic therapies.
Pioneering a Different Approach
Some companies have been pioneering a completely different approach targeting atherosclerotic plaque itself, rather than trying to reduce it by reducing LDL cholesterol levels in blood serum. AtheroNova Inc. (AHRO) is one such company that believes regression and stabilization of plaque – not LDL cholesterol – will become the new gold standard in the treatment and prevention of cardiovascular disease.
The company’s AHRO-001 uses naturally occurring compounds normally found in the digestive tract to dissolve, or delipidize, the portions of the soft, vulnerable plaque that are accessible through the fibrous cap. The process breaks down plaque deposits into molecules small enough to pass safely through the fibrous cap without causing harm to the fibrous cap itself. The result is a potential treatment that would emulsify plaque, decrease cholesterol absorption, increase the efficiency of HDL cholesterol and ultimately provide atheroprotective effects.
In preclinical studies, AHRO-001 did not show adverse effects, including morbidity or mortality, and was well tolerated at high doses. Early efficacy results were also promising in the pre-clinical trials at UCLA and Cedars-Sinai, with a 95% reduction in innominate arterial plaque formation versus the control group. Interestingly, Ursodiol, a pharmaceutical based on a similar naturally occurring compound, has received approval from the FDA to treat primary biliary cirrhosis and gallstones, with millions of patients taking it without significant side effects.
Potential Opportunity for Investors
With cardiovascular disease being the number one cause of death globally, with an estimated 23.6 million people dying by 2030, the potential implications of a successful treatment of atherosclerotic plaque are enormous. Plaque regression is a new paradigm and future atherosclerosis treatment that marks a significant step away from increasingly problematic associations with LDL cholesterol levels and towards more direct efficacy by tangibly removing atherosclerotic plaque deposits using a completely natural compound.
Investors interested in this next generation of atherosclerosis treatment may want to take a look at companies like AtheroNova Inc. (AHRO). With promising results in preclinical trials, the stock could see significant upside over the coming quarters as it works to complete a Phase I clinical trial and explores potential partnership opportunities along the way. Meanwhile, the company has also started catching the attention of investors and analysts on Wall Street, which could set the stage for greater liquidity and exposure down the road.
On February 19, 2013, Mont Blanc Capital Equity Research initiated coverage on the company with a “buy” rating and $2.00 per share price target, saying that it believes upside to the stock price is significant over the next two years as it moves through Phase I and Phase II trials. The price target is based on the firm’s net present value model that uses the terms of the February 2013 licensing agreement between Alnylam Pharamceuticals and The Medicines Company as a comparable, and also meets the low end of the post-Phase II clinical trial license agreement comparables using a more conservative 40% discount rate.
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