FDA Accepts Use of New High-Throughput Manufacturing Process for Nomacopan in Pivotal Clinical Studies


New manufacturing process increases final yield of nomacopan by at least 5 times, significantly reducing cost of goods for clinical studies and commercialization

NEW YORK and LONDON, Jan. 19, 2022 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapies to treat orphan autoimmune and inflammatory diseases where complement ( C5) and/or leukotriene (LTB4) systems are involved, today announced that the U.S. Food and Drug Administration (FDA) has accepted, via a Type C meeting, the clinical use of the derivative nomacopan of a new generation manufacturing process. Nomacopan is Akari’s lead drug candidate currently in two Phase III programs.

The FDA has agreed that the new manufacturing process produces a drug comparable to nomacopan from the previous manufacturing process. The new manufacturing process increases the final yield of nomacopan by at least 5 times, compared to the previous manufacturing process, which will significantly reduce the future commercial cost of goods and reduce the cost of ongoing Phase II/III programs and future clinical development programs for nomacopan.

“FDA approval for our use of the new, improved manufacturing process is a key step on the road to commercialization of nomacopan,” said Miles Nunn, Ph.D., chief scientific officer of Akari Therapeutics. “The FDA clearance is the culmination of years of work, and I would like to thank Akari’s CMC Manager, Mukesh Sehdev, and our long-time partners in nomacopan manufacturing, Wacker Biotechnology GmbH and Solvias AG, for their strategic planning. , their commitment and the quality of their work.

About Akari Therapeutics

Akari is a biopharmaceutical company focused on the development of acute and chronic inflammation inhibitors, specifically for the treatment of rare and orphan diseases, particularly those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes, play a primary role in disease progression. Akari’s lead drug candidate, Nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently undergoing clinical evaluation in four areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), as well as ocular and pulmonary programs.

Caution Regarding Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current beliefs about our plans, intentions, expectations, strategies and prospects, which are based on on the information currently available to us and the assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected or implied by these forward-looking statements are reasonable, we cannot guarantee that the plans, intentions, expectations or strategies will be achieved or achieved. In addition, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors beyond our control. These risks and uncertainties to our company include, but are not limited to: additional capital requirements to fund our operations; our ability to continue our business; cash flow uncertainties and the inability to meet working capital requirements; failure or delay in obtaining required regulatory approvals for Nomacopan and any other product candidates, which may result in unforeseen expenses; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development generally; uncertainties regarding the achievement of positive clinical results for Nomacopan and any other product candidates and the unexpected costs that may result; difficulties in recruiting patients into our clinical trials; our ability to enter into collaborative, licensing and other commercial relationships and on terms that are commercially reasonable to us; the inability to realize the value of Nomacopan and any other product candidates developed and under development in light of the inherent risks and difficulties inherent in bringing product candidates to market; failure to develop new product candidates and support existing product candidates; the approval by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and any other similar foreign regulatory authority of other competing or superior products brought to market; risks resulting from unforeseen side effects; the risk that the market for Nomacopan will not be as large as expected; risks associated with the impact of the COVID-19 pandemic; the inability to obtain, maintain and enforce patents and other intellectual property rights or the unforeseen costs associated with such application or litigation; the inability to obtain and maintain commercial manufacturing agreements with third-party manufacturers or establish commercial-scale manufacturing capabilities; the inability to timely source adequate quantities of our active pharmaceutical ingredients from third-party manufacturers on which the Company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the Securities and Exchange Commission (SEC), including our most recently filed Annual Report on Form 20-F filed with the SEC . Unless otherwise stated, these forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after such date. Press release. We caution investors not to place significant reliance on any forward-looking statements contained in this press release.

For more information

Contact Investor

Pierre Vozzo
ICR Westwicke
(443) 213-0505
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Sukaina Virji / Maya Bennison
Consilium Strategic Communications
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