Akari Therapeutics announced the approval by the UK Medicines & Healthcare products Regulatory Agency (MHRA) to conduct a Phase IB multiple ascending dose trial. 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).

This Phase IB multiple ascending dose vehicle controlled double-blind trial is designed to determine the maintenance dose of Coversin when given as a daily, fixed-dose, subcutaneous injection that leads to complete inhibition of Complement C5. As demonstrated in the Phase IA single dose trial, a single subcutaneous injection of Coversin at a dose of 0.57mg/kg completely inhibited complement activity by 12 hours in healthy volunteers. In this Phase IB multiple ascending dose vehicle controlled double-blind trial, cohorts of healthy volunteers will receive an ablating dose, followed by 4-6 days of a lower maintenance dose after which complement activity will be measured.

The purpose of the trial is to determine the lowest fixed dose at which Coversin completely inhibits complement activity at a 24-hour trough level following the last dose given. Topline results from the trial are expected by the end of the first quarter of 2016 or early second quarter 2016.