Coversin Gets Fast Track Status for Paroxysmal Nocturnal Hemoglobinuria
The Food and Drug Administration (FDA) has granted Fast Track designation for Coversin (Akari Therapeutics) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in patients who have polymorphisms conferring eculizumab resistance.
PNH is an ultra-rare, life-threatening and debilitating hematological disorder. It is an autoimmune disease due to an acquired genetic deficiency which causes dysregulation or uncontrolled activation of the complement component of the immune system.
Akari is currently investigating Coversin in two Phase 2 clinical trials in patients with PNH. The first study is evaluating Coversin in patients who have never received a complement-blocking therapy while the second study is evaluating the drug in patients with C5 polymorphisms resistant to eculizumab. Both trials are ongoing and results will be presented in the future.
Coversin is a subcutaneous, second-generation complement inhibitor designed to act on complement component-C5 to prevent the release of C5a and the formation of the membrane attack complex (MAC) or C5b-9. Independently, LTB4 activity is also inhibited.
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