Potential Ebola Hemorrhagic Fever Therapy Granted Orphan Drug Status

ARCA biopharma announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Recombinant Nematode Anticoagulation Protein c2 (rNAPc2) as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus. rNAPc2 is a potent and selective inhibitor of tissue factor (TF).

rNAPc2 has previously demonstrated post-exposure efficacy in non-human primate models of Ebola hemorrhagic fever virus (HFV). This investigational product 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.

The rationale for rNAPc2 as a HFV therapy stems from the role of TF in HFV mediated disseminated intravascular coagulation (DIC). Previous research studies have shown that abnormal activation of TF is a common element of the host response to infection from Ebola, Marburg and other HFVs. This activation of TF results in a systemic consumption coagulopathy and related inflammation, which is believed to be partially responsible for the high morbidity and mortality caused by these infections.

ARCA is not actively developing rNAPc2 for any indications and has no plans to begin such development without securing a partnership, an out-licensing agreement, or receiving grant or government funding.

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