Akari Therapeutics Offers Update from Non-Human Primate Safety Study at PNH Interest Group Annual Meeting

Akari Therapeutics

, an emerging growth, development-stage biopharmaceutical company, provided an update from its 28 day non-human primate (NHP) safety study at the International PNH Interest Group 10th Annual Scientific Meeting held on December 4th, 2015 in Orlando, Florida. The study tested Coversin daily subcutaneous injection for 28 days at a low and high dose versus placebo in 24 non-human primates and demonstrated no safety issues, adverse events or injection site reactions. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS). "In this study, we demonstrated steady state complete complement inhibition in non-human primates given a single daily subcutaneous dose of Coversin. The steady state was achieved even though in non-human primates, Coversin had a more rapid onset and offset of action compared to that seen in our Phase Ia healthy volunteer data," said Miles Nunn, Chief Scientific Officer of Akari Therapeutics. "After a single injection in non-human primates, complement activity in the high dose group returned to 25% of baseline by 24 hours, compared to about 5% of baseline by 24 hours in the 0.57mg/kg cohort of our Phase Ia healthy volunteer study." "The non-human primate safety and complement inhibition data strengthen our belief that daily subcutaneous administration of Coversin in humans at an appropriate dose, to be determined in our upcoming Phase 1b study, should provide complete and highly stable chronic complement inhibition," said Gur Roshwalb, Chief Executive Officer of Akari Therapeutics. "We believe that Coversin has the potential to be the best-in-class second generation complement C5 inhibitor in development." Full data from this safety study will be presented at a future scientific forum.