FDA Agrees to Use of New Manufacturing Process for Nomacopan in Clinical Studies

Akari Therapeutics, Plc, a late-stage biopharmaceutical company focused on therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, has announced that the U.S. Food and Drug Administration ( FDA ) has agreed, via a Type C meeting, to the clinical use of nomacopan derived from a next generation manufacturing process. Nomacopan is Akari's lead drug candidate currently in two Phase III programs.

The FDA agreed that the new manufacturing process produces a drug that is comparable to nomacopan from the prior manufacturing process. The new manufacturing process increases the final yield of nomacopan at least five-fold, compared to the previous manufacturing process, which will significantly decrease future commercial cost of goods and reduce the cost of ongoing Phase II /III and future clinical development programs for nomacopan.

"FDA's agreement for our use of the new and enhanced manufacturing process is a key milestone in the pathway to commercialization of nomacopan," said Miles Nunn, Ph.D., chief scientific officer of Akari Therapeutics. "The FDA's agreement is the culmination of several years' work, and I would like to thank Akari's Head of CMC , Mukesh Sehdev, and our long-term partners in the manufacture of nomacopan, Wacker Biotechnology GmbH and Solvias AG, for their strategic planning, commitment and the quality of their work."