Benzinga | Jan 19, 2022 08:36AM EST

Akari Therapeutics Reports FDA Has Agreed To The Clinical Use Of Co.'s Nomacopan Derived From Next-Gen Manufacturing Process

Akari Therapeutics, Plc (NASDAQ:AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today 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 drug that is comparable to nomacopan from the prior manufacturing process. The new manufacturing process increases the final yield of nomacopan at least 5-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."