Akari Gets Great News On Blood Disease Drug

(RTTNews) - Akari Therapeutics Plc (AKTX), a clinical-stage biopharmaceutical company, reported positive results in a mid-stage clinical trial for its lead drug Coversin for a rare blood disease. The company's shares which surged almost 10 percent in pre-market activity, are currently losing more than 11 percent.

Coversin's potential is being explored in the indications of paroxysmal nocturnal haemoglobinuria, atypical Hemolytic Uremic Syndrome or aHUS, and Guillain Barré syndrome or GBS. Paroxysmal nocturnal haemoglobinuria, or PNH, is an ultra-rare blood disorder in which the red blood cells break apart prematurely.

Akari said it will present data from the interim analysis of its ongoing Phase 2 trial of Coversin in PNH at today's Research and Development Day.

Five patients with PNH were enrolled in the 90 day, open label Phase 2 trial conducted at five centers in the EU. These patients, who had not received prior anti-complement therapy, were treated with Coversin self-administered subcutaneous injections twice a day for approximately the first month and then switched to once daily injections.

The primary endpoint in the trial is reduction in serum LDH to 500 IU/L, whichever is the lower from day 1 to day 28. Secondary endpoints are LDH at days 60 and 90, hemoglobin, CH50, quality of life, and transfusion independence.

Akari noted that four of the five patients who remain on Coversin achieved LDH reductions. They are also symptom free and without any serious adverse events.

"All patients are comfortable with self-dosing and by the end of May, we plan to have the four continuing patients from this Phase 2 and the one patient from the eculizumab resistant protocol on long term treatment in our long term open label safety trial," Akari said.

The company plans to begin a phase 3 clinical trial in PNH in the fourth quarter of 2017, with initial data anticipated in the first quarter of 2019.