Plans to start Coversin Phase III in PNH in Q1 2018
NEW YORK and LONDON, September 21, 2017 (GLOBE NEWSWIRE) — Akari Therapeutics (NASDAQ: AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, 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.
“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.”
Akari plans to carry out two Phase III clinical studies: CAPSTONE, in naïve 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.
