Akari Therapeutics completes enrollment in COBALT Phase II PNH trial of Coversin
Akari Therapeutics announces that three additional patients have been enrolled in the ongoing Phase II COBALT clinical trial of Coversin in patients with paroxysmal nocturnal hemoglobinuria, or PNH. COBALT, the Phase II 90-day, open label single arm clinical trial, has enrolled a total of eight patients, four of whom have completed the trial and were reported on at the European Hematology Association conference in June 2017. These four patients have all moved into Akari's long-term safety study, CONSERVE. One of the initial five patients enrolled in the COBALT trial, with a suspected co-morbidity unrelated to the treatment, was withdrawn from the study on day 43. Three new patients were enrolled pursuant to an amended protocol based on a revised dosing regimen which included changing the maintenance phase from a single dose of 30mg every 24 hours to a single dose of 45mg every 24 hours. The three newly enrolled patients on the revised dosing regimen have now completed approximately 8, 3 and 2 weeks, respectively. The primary endpoint in this clinical trial is reduction in serum LDH, or lactate dehydrogenase; an indication of hemolysis, to less than or equal to 1.8 times the ULN, or upper limit of normal, for the investigator's reference laboratory or 500 I U/L, whichever is the lower from day 1 to day 28. The first of the three patients had a LDH value of 1.5 times the ULN at day 28. The other two patients have not yet reached the primary endpoint measurement date. To date, there have been no drug-related serious adverse events. The data reported is taken from the current electronic case report forms. Akari plans to provide an update on all PNH patients currently enrolled at the American Society of Hematology Annual Meeting to be held December 9-12, 2017. Akari plans to advance Coversin towards Phase III clinical trials beginning with CAPSTONE in Q1 2018, a Phase III clinical trial of Coversin in naive PNH patients.