=Akari Therapeutics (AKTX) : regulatory progress following FDA meeting

Akari Therapeutics plans to advance Coversin towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria in 1Q18

The co announces that, following advice from a recent FDA Type B End of Phase II Meeting, it plans to advance its lead investigational drug, Coversin, towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Q1 2018.

• Akari plans to carry out two Phase III clinical studies: CAPSTONE, in nave PNH patients where eculizumab (Soliris; Alexion) is not the standard of care, with co-primary clinical endpoints based on hemoglobin and transfusion data, and ASSET, a Phase III clinical study switching PNH patients from eculizumab, the current standard of care treatment in PNH in the U.S., to treatment with Coversin.
• The FDA indicated that providing safety and efficacy data from the Company's clinical trials for the proposed number of unique PNH patients on Coversin for more than one year seems reasonable, subject to review of the actual data upon submission. The number proposed includes patients having C5 polymorphisms conferring eculizumab resistance.