QUARTERLY UPDATE: AtheroNova (AHRO-OTC) Prepares for Phase I Trials

Posted by Laura Swartz

October 19, 2012 at 9:34 AM

This morning, we issued a Quarterly Update on AtheroNova Inc. (AHRO-OTC.BB), a development-stage biotech company creating novel compounds to dissolve or regress atherosclerotic plaque deposits. AtheroNova's most advanced product candidate, AHRO-001, works to significantly reduce the incidence and severity of plaque by employing a type of FDA-approved compound called a bile salt. In doing so, the Company seeks to address a +$37 billion market for lipid regulators--the drugs currently used to treat atherosclerosis and coronary artery disease. Atherosclerosis is a thickening of the arteries that occurs when fat, cholesterol, and other substances build up in the walls of the arteries and harden into plaque deposits. It is the primary cause of many cardiovascular diseases, including heart attack, stroke, and peripheral artery disease.

Importantly, lipid regulators, while effective at reducing serum cholesterol levels, are not effective at reducing plaque at commonly prescribed dosages. They are also associated with tolerability concerns and may pose complications resulting from long-term use. AtheroNova seeks to address the unmet need in this market for products that can both dissolve existing plaque deposits as well as prevent new ones from forming.

Highlights from the Quarterly Update are presented below. To view the research, click here.

  • AtheroNova is preparing to commence Phase I clinical trials of its lead bile acid-based candidate, AHRO-001, in the fourth quarter 2012 with its research and development partner, Russia-based CardioNova, Ltd. The Company is in the process of manufacturing and delivering the first batch of clinical trial material for use in the Phase I trials. AtheroNova expects to complete Phase I trials and file an IND with the FDA by the first quarter 2013, followed by a Phase II clinical study.

  • In July 2012, AtheroNova received a Notice of Allowance from the U.S. Patent and Trademark Office regarding its proprietary method of treating atherosclerosis using a bile acid. The Notice of Allowance allows the Company to continue its development of AHRO-001, as well as to seek additional pipeline candidates in the AHRO family for treatment of obesity, hypertension, diabetes, PAD, localized transdermal fat dissolution, and the non-invasive dissolution of lipomas.

  • Lipid regulators, specifically statins, are the most effective method for reducing serum cholesterol levels, with blockbuster status of $37 billion in revenues in 2010 (Source: IMS Health, Inc.). At commonly prescribed dosages, however, they are not effective at reducing plaque, have drawbacks with tolerability, and may pose complications resulting from long-term use.

  • The Company successfully completed preclinical studies with UCLA and Cedars-Sinai, with results to be published in scientific journals for the UCLA study in late 2012 and for Cedars-Sinai by early 2013. In these studies, use of AHRO-001 led to a 95% reduction in innominate arterial plaque formation versus the control group. The compound has not shown morbidity, adverse effects, or mortality and was well tolerated at high doses.

  • AtheroNova continues to generate investor awareness, having recently presented at two investor conferences. As well, the Company announced on October 11, 2012, that it had raised over $2.9 million in gross proceeds from a sale of its Common Stock, representing a major milestone as the funding is expected to support both Phase I and Phase II clinical trials.

  • For the quarter ended June 30, 2012, AtheroNova’s net income was $339,157 versus a net loss of $447,684 for the same period 2011, due to the gains generated from the revaluations of the Company’s derivative liabilities. This gain was partially offset by increases in payroll, stock-based compensation, and costs associated with the development of AHRO-001. As of June 30, 2012, AtheroNova held over $412,605 in cash. 

Topics: AtheroNova

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