- The FDA grants Orphan Drug status to Arca biopharma's (NASDAQ:ABIO +3.6%) TF inhibitor, rNAPc2, for the treatment of hemorrhagic fever. The two most deadly hemorrhagic fever viruses (HFV) are Ebola and Marburg.
- rNAPc2 (Recombinant Nematode Anticoagulation Protein c2) was originally developed as a cardiovascular therapy for thrombosis and other indications. It inhibits tissue factor (TF), a protein responsible for initiating the primary coagulation mechanism in humans.
- The rationale for the use of rNAPc2 in hemorrhagic fever relates to role of TF in HFV-mediated disseminated intravascular coagulation, an often fatal complication that leads to spontaneous hemorrhage. TF activation results in a systemic consumption coagulopathy and related inflammation which contributes to the high morbidity and mortality of HFV infection.
- Arca is not actively developing rNAPc2 in this indication and will not do so unless it secures a development partner, an out-licensing agreement or external funding.
- Among the benefits of Orphan Drug status is a seven-year period of exclusivity after approval.