Metabolic Syndrome ("MS") affects approximately a quarter of the U.S. population, according to a 2002 National Health and Nutrition Examination Survey. Characterized by raised triglycerides, reduced HDL cholesterol, high BMI/waistline, raised blood pressure, and raised fasting plasma glucose, the syndrome significantly increases the risk of heart disease and a host of other health problems, including stroke, diabetes and some common forms of cancer.
may be surprised that LDL cholesterol is absent from the list, despite the fact
that the media has demonized cholesterol. Meanwhile, companies like Pfizer Inc.
(NYSE: PFE), Merck & Co. (NYSE: MRK) and AstraZeneca plc (NYSE: AZN) have
all built multi-billion dollar statin drugs designed specifically to reduce LDL
cholesterol. In reality, a broader approach may be necessary and these statins
may need to be supplemented with additional drugs.
produced by these companies have been shown to modestly raise HDL cholesterol
levels, investors may want to take a look at a newer company with a compound
that has the potential to address multiple aspects of Metabolic Syndrome.
AtheroNova Inc.'s (OTCQB: AHRO) AHRO-001 uses natural bile salts to reduce several
metabolic syndrome factors as well as possible regression of atherosclerosis by
lowering fasting plasma glucose levels, reducing cholesterol absorption, and
improving HDL cholesterol function.
Taking a Natural Approach
recently announced preclinical study results outlining the potential of
AHRO-001 in the FASEB Journal – one of the world's most cited biology journals.
The pre-clinical study, entitled Hyodeoxycholic
acid improves HDL function and inhibits atherosclerotic lesion formation in
LDLR-knockout mice – examined the effects of AHRO-001's active ingredient –
hyodeoxycholic acid – on lipid metabolism and atherosclerosis in LDL receptor-null
("LDLRKO") lab mice.
the study's abstract:
We observed that mice fed the
[hyodeoxycholic acid] diet were leaner and exhibited a 37%(P<0.05) decrease
in fasting plasma glucose level. HDCA supplementation significantly decreased
atherosclerotic lesion size at the aortic root region, the entire aorta, and
the innominate artery by 44% (P<0.0001), 48%, (P<0.01), and 94% (P<0.01), respectively … Plasma VLDL/IDL/LDL cholesterol levels were
significantly decreased, by 61% (P<0.05) … HDCA supplementation decreased
intestinal cholesterol absorption by 76% (P<0.0001) … HDL isolated from the
HDCA group exhibited significantly increased ability to mediate cholesterol
efflux ex vivo.
The key points
in this excerpt are the fact that fasting glucose levels were significantly
reduced and HDL cholesterol function improved – addressing two key factors in
Metabolic Syndrome. Moreover, the results section of the study highlights the
fact that the HDCA mice had a 10% lower bodyweight, significantly decreased fat
mass, and increased lean mass, which are other positive results with regards to
BMI and waistline components of Metabolic Syndrome.
cholesterol levels were also significantly lowered, the reduction in
atherosclerotic lesion size is arguably far more important and demonstrates
AHRO-001's efficacy in reducing the key problem rather than a potentially
contributing factor. This may make the compound a great addition to other drugs
on the market, if similar results can be replicated in humans, while addressing
a larger number of potential end markets for Metabolic Disease.
Looking at the Road Ahead
pre-clinical results above represent a significant step forward for AtheroNova
and its investors, demonstrating the safety and efficacy of AHRO-001 in mouse
models. As we've explored, the compound appears to address many of the
underlying causes of Metabolic Syndrome instead of focusing on just one
component, which could make it more effective in treating heart disease, while
opening the door to many other indications.
On June 25,
2013, the company announced the initiation of a Phase I clinical trial with
AHRO-001 that will evaluate its safety, tolerability, and pharmacokinetics in
healthy volunteers. The study is being conducted in Russia with its licensing
partner, OOO CardioNova, and will be a randomized, double-blind, placebo
controlled study that uses ascending doses. Results from the Phase I study are
expected to come later this year or early next year with Phase II starting in Q2
AHRO-001's preclinical profile, we believe it has the potential to offer
patients effective treatment for these chronic conditions with an improved
therapeutic profile," said Chairman and CEO Thomas W. Gardner in a recent press
release announcing the Phase I trial. "We look forward to assessing AHRO-001 in
human trials and are extremely pleased to have met a signification milestone
with transitioning into a clinical stage company."
interested in companies targeting Metabolic Syndrome, from Arena
Pharmaceuticals Inc. (NASDAQ: ARNA) to VIVUS Inc. (NASDAQ: VVUS), may want to
consider taking a position in AtheroNova as these clinical trials progress and
additional data becomes available. While additional trials are necessary before
an approved drug, there are many pre-clinical positive indications and major
pharmaceutical giants are likely already watching closely.
information, please see www.atheronova.com
or read the complete pre-clinical study at the following URL: http://www.fasebj.org/content/early/2013/06/10/fj.12-223008.short.
Investors can also watch the company's virtual 2013 annual meeting online at https://central.virtualshareholdermeeting.com/vsm/web.do?pvskey=AHRO.
Learn more and request information on AtheroNova (AHRO) here:
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