Akari Therapeutics Announces a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgica...
March 04 2021 - 8:30AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company
focused on innovative therapeutics to treat orphan autoimmune and
inflammatory diseases where the complement and/or leukotriene
systems are implicated, today announced a cooperative research and
development agreement (CRADA) with the U S. Army Institute of
Surgical Research (USAISR), working to evaluate the potential for
use of nomacopan in civilian and battlefield trauma for which there
are currently no approved therapies.
Dr Miles Nunn, Chief Scientific Officer of Akari Therapeutics
said, “Nomacopan has shown encouraging results in trauma-related
conditions including traumatic brain injury1, immune
complex-induced acute lung injury2, myocardial infarction3 and
blast injury. The dual inhibition of C5 and LTB4 by nomacopan for
the treatment of trauma is supported by a large body of literature4
reflecting the harmful role for both these inflammatory mediators
in the early pathophysiology of trauma and haemorrhagic shock.”
Akari has established a collaboration with the USAISR via a
CRADA to evaluate the activity of nomacopan in preclinical trauma
and haemorrhagic shock models.
Trauma is a global burden disease in civilians and service
members and is the leading cause of death for individuals up to the
age of 45 years. Annual total U.S. inpatient trauma-related
hospital costs are approximately $30 billion5. In the U.S. there
are approximately 500,000 trauma hospital discharges a year which
are defined as severe and might benefit from early drug
intervention to reduce multi-organ dysfunction following
trauma.
Nomacopan’s unique dual binding of C5 and LTB4 targets the
adverse inflammatory roles of both the complement and leukotriene
pathways in trauma for which there are no currently approved
therapies. The secondary neuroinflammation and neuronal damage that
follows the primary traumatic injury is an important cause of
morbidity in affected people and the role of both the leukotriene
and complement pathways are well documented in trauma, which
underpins the potential therapeutic benefit of the dual action of
nomacopan.
The ongoing work with nomacopan is focused on preliminary
evaluations of biological effects in large animal trauma models.
Additional studies will be required to establish the safety and
biological activity of nomacopan in contaminated wound models
relevant to battlefield conditions. Nomacopan does not require
special handling, can be carried in small vials and can be quickly
reconstituted in small volumes of fluid, which may facilitate its
use in prehospital settings.
Clive Richardson, Chief Executive Officer of Akari Therapeutics
said, “There are currently no drugs approved for trauma to improve
survival and recovery. With nomacopan, Akari’s goal is to make a
significant contribution to trauma recovery for the benefit of the
U.S. armed forces as well as to the wider civilian population.”
Source:
1) (Fluiter et al.,
2014),2) (Roversi et al.,
2013)3) (Pischke et al.,
2017)4) (Sadik et al., 2018; Auner et al., 2012;
Li et al., 2019; Yang et al., 2019; Rittirsch et al., 2012;
Störmann et al., 2017; Tanaka et al., 1997; Brady et al., 1992;
Solomkin 1990)5) (DiMaggio et al., 2016)
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
indications: bullous pemphigoid (BP), atopic keratoconjunctivitis
(AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal
hemoglobinuria (PNH). Akari believes that the dual action of
Nomacopan on both C5 and LTB4 may be particularly beneficial in AKC
and BP. Akari is also developing other tick derived proteins,
including longer acting versions.
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; 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 FDA and 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 departure of our
former Chief Executive Officers and other executive officers; risks
associated with the SEC investigation; 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 U.S. Securities and Exchange Commission, 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 informationInvestor Contact:
Peter VozzoWestwicke/ICR(443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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