FDA Agrees to Use of New Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Studies
20 January 2022 - 12:30AM
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.”
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing
inhibitors of acute and chronic inflammation, specifically for the
treatment of rare and orphan diseases, in particular those where
the complement (C5) or leukotriene (LTB4) systems, or both
complement and leukotrienes together, 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 being clinically evaluated in four
areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA),
as well as programs in the eye and lung.
Cautionary Note 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 views about our plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to us and on assumptions we have
made. Although we believe that our plans, intentions, expectations,
strategies and prospects as reflected in or suggested by those
forward-looking statements are reasonable, we can give no assurance
that the plans, intentions, expectations or strategies will be
attained or achieved. Furthermore, actual results may differ
materially from those described in the forward-looking statements
and will be affected by a variety of risks and factors that are
beyond our control. Such risks and uncertainties for our company
include, but are not limited to: needs for additional capital to
fund our operations, our ability to continue as a going concern;
uncertainties of cash flows and inability to meet working capital
needs; an inability or delay in obtaining required regulatory
approvals for Nomacopan and any other product candidates, which may
result in unexpected cost expenditures; our ability to obtain
orphan drug designation in additional indications; risks inherent
in drug development in general; uncertainties in obtaining
successful clinical results for Nomacopan and any other product
candidates and unexpected costs that may result therefrom;
difficulties enrolling patients in our clinical trials; our ability
to enter into collaborative, licensing, and other commercial
relationships and on terms commercially reasonable to us; failure
to realize any value of Nomacopan and any other product candidates
developed and being developed in light of inherent risks and
difficulties involved in successfully bringing product candidates
to market; inability to develop new product candidates and support
existing product candidates; the approval by the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) and any
other similar foreign regulatory authorities of other competing or
superior products brought to market; risks resulting from
unforeseen side effects; risk that the market for Nomacopan may not
be as large as expected; risks associated with the impact of the
COVID-19 pandemic; inability to obtain, maintain and enforce
patents and other intellectual property rights or the unexpected
costs associated with such enforcement or litigation; inability to
obtain and maintain commercial manufacturing arrangements with
third party manufacturers or establish commercial scale
manufacturing capabilities; the inability to timely source adequate
supply of our active pharmaceutical ingredients from third party
manufacturers on whom 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. Except as otherwise noted, 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
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release.
For more information
Investor Contact
Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Media Contact
Sukaina Virji / Maya BennisonConsilium Strategic
Communications+44 (0)20 3709 5700Akari@consilium-comms.com
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