Heart failure has always been one of the predominant fatal human conditions, therefore this week I will be focusing on ARCA Biopharma (ABIO), which has developed a highly successful treatment.
The broad world market for this drug is truly spectacular.
Here are some common facts: Heart failure becomes more common with increasing age. About 1 in 35 people aged 65-74 years have heart failure. This increases to about 1 in 15 of people aged 75-84 years, and to just over 1 in 7 people aged 85 years and above. It is uncommon in younger people.
It is difficult to give an outlook (prognosis) for an individual. In general, the more severe the heart failure, the worse the outlook. In many cases, the symptoms remain at a stable level for quite some time (months or years) before becomming worse. In some cases the severity and symptoms become gradually worse over time. Severe heart failure can lead to death.
In many cases, the symptoms of heart failure can be eased with treatment. Treatment not only eases symptoms but can improve prognosis and prolong life.
About: ARCA Biopharma, Inc., formerly Nuvelo, Inc. is a biopharmaceutical company focused on developing genetically-targeted therapies for heart failure and other cardiovascular diseases. ARCA’s lead product candidate Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator, is under review by the United States Food and Drug Administration (FDA), for chronic heart failure (HF).
FDA News: Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
Gencaro Positive Phase III Results: Arca Biopharma reports overall survival benefit from heart failure trial. 92% of the projected primary endpoint events available. Arca Biopharma has reported data from the pivotal Phase III Best trial of Gencaro in patients with advanced chronic heart failure. The trial results demonstrated that, in a demographically diverse group of primarily US patients with New York Heart Association class III and IV heart failure, Gencaro treatment resulted in a near significant overall survival benefit and statistically significant benefits in slowing progression of heart failure, the company said.
Average follow-up shortened by 12 months, said Arca Biopharma.
All eight secondary endpoints of the trial were positive and statistically significant. As pre-specified with the FDA, the composite endpoint of heart failure progression was the most important secondary endpoint, with Gencaro shown to be superior to placebo for slowing progression of heart failure (HR 0.80, p=0.00003), and for the endpoint’s components of heart failure-related mortality (HR 0.85, p=0.042), heart failure-related hospital admission (HR 0.77, p=0.00002), and heart failure-related emergency room visits (HR 0.74, p=0.024).
Zacks.com Bullish Signal: ARCA biopharma Inc’s MACD indicator has moved into positive territory with a reading of 0.0681, representing a bullish turn in this Zacks #1 Rank (“Strong Buy”) stock. Analysts on average see the company’s fiscal 2009 earnings improving to a loss of $10.6 per share compared to the earlier forecast of $11.9.