ARCA biopharma (ABIO): Leveraging Genetic Targeting to Better Treat Cardiovascular Disease

REDONDO BEACH, CA / ACCESSWIRE / September 15, 2015 / Cardiovascular disease is responsible for one-in-four deaths each year in the United States, or roughly 610,000 deaths each year, making it the leading cause of death in both men and women, according to the Centers for Disease Control. Despite causing more deaths than cancer each year, many cardiovascular drugs are based on loose associations rather than the precision genetic targeting that underlies many oncology drugs.

For example, Pfizer Inc.'s (NYSE: PFE) crizotinib and AstraZeneca plc's (NYSE: AZN) AZD9291 target specific genes within tumors to inhibit their growth. By comparison, the most widely prescribed cardiovascular drugs - statins - simply lower a type of cholesterol that has been associated with reducing the risk of heart disease. Absolute risk reductions may in fact be negligible, according to some meta studies.

ARCA biopharma Inc. (NASDAQ: ABIO) aims to bring genetic targeting to cardiovascular disease management, with an initial focus on developing the first genetically-targeted treatment for atrial fibrillation ("AF"). The company's lead product candidate, Gencaro, is a beta-blocker and mild vasodilator currently being evaluated in a Phase IIB/III clinical trial in a genetically defined population. If approved, the company believes the drug candidate has the potential for annual sales of $450 million to $900 million given the significant unmet need.

Currently, beta blockers are used off-label for the treatment of AF in patients with heart failure, with a 27% average reduction in incidence of new onset AF in heart failure where AF was reported. In a prior Phase III clinical trial, data indicated that a subset of the patient population - with a genotype called ADRB1 Arg389Arg - had a 74% reduction in the incidence of new onset AF in heart failure patients. This genotype is present in roughly half of the U.S. population, which makes it a good candidate for a genetically targeted treatment.


The company is targeting atrial fibrillation in heart failure patients where, based on prior data, it's new drug candidate has the potential to be effective where there aren't any existing drugs currently approved by the U.S. FDA.

Significant Unmet Need with Well-Defined Pathway

Atrial fibrillation is the most common type of heart arrhythmia, where the upper chambers of the heart beat irregularly and blood doesn't flow as well as it should from the atria to the lower chambers of the heart. According to the CDC, 2.7 to 6.1 million U.S. citizens are affected with the condition, while the aging population will increase these figures over time. The condition causes 750,000 hospitalizations and an estimated 130,000 deaths each year.

Treatment options for atrial fibrillation vary from medications used to control the heart's rhythm and rate, such as Bristol Myers Squibb’s (NYSE: BMY) Coumadin(R), to medical devices, such as Boston Scientific Inc.'s (NYSE: BSX) WATCHMAN device that was approved in March of 2015. Surgery and lifestyle factors may also be prescribed in order to help reduce the changes of arrhythmias occurring in some cases, such as the ablation surgical procedure.

ARCA will use clinical endpoints for its trial that are similar to those used for the most recent AF FDA approvals, while the drug's safety profile is already well-understood based on prior development as a beta-blocker. The Gencaro development program received Fast Track designation from the FDA earlier this year. The Gencaro clinical trial, GENETIC-AF, is currently enrolling patients in the U.S. and Canada. Management believes that it will have approximately 65 active clinical sites by Q4 2015, complete enrollment of 200 patients for the Phase 2B portion of the trial by the end of 2016, and potentially convert to Phase III in the first half of 2017.

The company is working with Lab Corp. (NYSE: LH) to identify patients with the ADRB1 ARg389Gly genotype for its GENETIC-AF clinical trial and Medtronic Inc. (NYSE: MDT) to monitor patients within its clinical trial using an implanted continuous monitoring device.

Strong Potential with an Experienced Team

ARCA's management team has extensive experience in the cardiovascular space in terms of both drug development and corporate execution. In the past, the team has demonstrated their ability to execute with prior success in clinical development and regulatory approvals. The large and growing AF market represents a significant unmet medical need when it comes to patients with HFREF, paving the way for potential annual sales of $450 million to $900 million.

In June of this year, the company raised $37 million from some of the best institutional investors in the biotech and pharmaceutical spaces, including Venrock, NEA, Franklin Templeton, RA Capital and Tekla Life Science Investors. With funding through the next two major clinical milestones, investors have an opportunity to invest in the stock at a time when several near-term catalysts are on the horizon without as high of a risk of dilution due to capital needs. The promising initial research, strong existing safety profile, and experienced team point to a strong potential for positive catalysts as the company enrolls patients and advances its clinical trial that could convert to a pivotal Phase III in 2017.

Investors in companies like Taxus Cardium Pharmaceuticals Group Inc. (OTC: CRXM) or Cytokinetics Inc. (NASDAQ: CYTK) may want to pay especially close attention to the company given its unique focus on precision medicine, while those involved with traditional cardiovascular companies may want to take a look as a potential opportunity to diversify into an up-and-coming area of the industry.

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To visit the company website go to www.arcabiopharma.com.

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Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. Emerging Growth LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Emerging Growth LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit: http://secfilings.com/Disclaimer.aspx.

SOURCE: Emerging Growth LLC

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