Akari Therapeutics (NASDAQ: AKTX) shares dipped sharply after the company reported completion of Phase II COBALT trial of Coversin in patients with PNH and further progress of clinical trials.
The biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announces additional data for its Phase II COBALT clinical trial and provides an update on other clinical trials with Coversin.
The final three patients enrolled in the eight patient 90-day open-label Phase II single-arm COBALT clinical trial for patients with PNH who have never received a complement blocking therapy, have now completed the trial. They had a median LDH (lactate dehydrogenase; an indicator of hemolysis) of <1.5 times the ULN (upper limit of normal) at day 28, day 60 and day 90.
As previously disclosed, these three patients utilized the higher 45mg per day subcutaneous dose of Coversin. The 45mg dosing regimen is the intended dose for the Phase III PNH trials of Coversin discussed with the U.S. Food and Drug Administration (FDA) in September 2017.
Of the seven patients who completed the COBALT trial, six were transfusion-dependent prior to the trial. Of those six patients, three have not required transfusions while on Coversin during the COBALT trial. All seven patients that completed the study had a CH50 level below the limit of quantification (<8 CH50 U Eq/mL) after the ablating dose phase indicating total blockade of the terminal complement pathway.
Akari share prices were going steadily downward in Tuesday trading, getting set to meet the closing bell down 20 cents, or 8.5%, to $2.16.
