Akari plans move into Phase III with rare disease candidate

New York-listed rare disease specialist Akari Therapeutics plans to initiate a Phase III study of lead candidate Coversin (complement C5-inhibitor rEV576).

The company, which was founded in the UK, says it decided to pursue the trial into Coversin as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), “following advice from a recent FDA type B end of Phase II meeting.”

Chief executive David Horn Solomon said: “We will continue to work closely with the FDA, benefitting from our fast track status in the USA, and with the EMA towards submissions in PNH.”

Akari plans to carry out two Phase III clinical studies: CAPSTONE, in naive PNH patients where Soliris (eculizumab) is not the standard of care, and ASSET, in which PNH patients will be switched from Soliris.