Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) reported that following advice from a latest FDA Type B End of Phase 2 Meeting, it intends to progress its lead investigational product, Coversin™, towards Phase 3 clinical trials in Paroxysmal Nocturnal Hemoglobinuria in Q1 2018.
Dr. David Horn Solomon, the CEO, expressed that following their recent FDA meeting, they are working to commence a Phase 3 clinical study of Coversin in PNH in Q1 2018. They will continue to work with the FDA, gaining from their Fast Track status in the EMA, and with the United States towards filing of a MAA and BLA, respectively, for Coversin in PNH.
Akari intends to carry out two Phase 3 clinical trials: CAPSTONE, in naïve Paroxysmal Nocturnal Hemoglobinuria patients where eculizumab is not the standard treatment, with co-primary clinical objectives based on transfusion and hemoglobin data, and ASSET, a Phase 3 clinical trial switching Paroxysmal Nocturnal Hemoglobinuria patients from eculizumab, the prevailing standard of care treatment in Paroxysmal Nocturnal Hemoglobinuria in the U.S., to cure with Coversin.
The U.S. FDA indicated that providing efficacy and safety data from the firm’s clinical studies for the planned count of unique PNH patients on Coversin for over one year appears reasonable, subject to assessment of the actual data upon filing. The count proposed comprises patients having C5 polymorphisms discussing eculizumab resistance.
Dr. Solomon expressed that Akari continues to gain momentum in its complement focused treatment by advancing Coversin towards Phase 3 in Paroxysmal Nocturnal Hemoglobinuria and Phase 2 in aHUS. With Coversin administered subcutaneously, patients may show greater independence following self-administration.
Phase 3 trials are also planned for numerous other indications where Coversin’s impact on both the leukotriene and complement pathways play a role. Its two major targets in this segment are atopic keratoconjunctivitis and severe bullous pemphigoid. Akari is a biopharmaceutical firm focused on the commercialization and development of innovative therapeutics to cure inflammatory and orphan autoimmune diseases.