AtheroNova's AHRO-001 Targets Much More than Cholesterol, Shows New UCLA Study
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.
Savvy readers 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.
While statins 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 atherosclerosis by lowering fasting plasma glucose levels, reducing cholesterol absorption, and improving HDL cholesterol function.
Taking a Wholesome Approach
AtheroNova 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 redceptor-null ("LDLRKO") lab mice.
According to 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.
While LDL 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
The positive 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 with a Phase II starting at the same time.
"Based on 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."
Investors 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.
For more information, please see 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.
Disclosure: I am long OTCQB:AHRO.