ARCA Biopharma Inc (ABIO)

[TradeSmart.ai]

ARCA biopharma Receives FDA Orphan Drug Designation for rNAPc2 as a Potential Treatment for Ebola.

rNAPc2 Previously Demonstrated Post-Exposure Efficacy in NHP Models of Ebola HFV

rNAPc2 Previously Tested in Over 700 Human Patients in Nine Phase 1 and 2 Cardiovascular Disease Clinical Trials

rNAPc2 Potentially Inhibits the Human Body’s Catastrophic Response to Hemorrhagic Fever Viruses Like Ebola

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to rNAPc2 as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus. The drug candidate has previously demonstrated post-exposure efficacy in non-human primate models of Ebola hemorrhagic fever virus (HFV). rNAPc2 was originally developed as a cardiovascular therapy for thrombosis and other indications. As a result, it has an extensive human clinical record, and has been safely tested in over 700 human patients in nine Phase 1 and 2 clinical trials for cardiovascular disease.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 individuals in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon marketing approval, as well as certain financial incentives that can help support its development.

$ABIO