Full Press Release Details
Akari Therapeutics Announces New Data Showing
A Significant Role for Complement Activation in the Clinical Outcomes of U.S. Army Trauma Patients in Iraq and the Therapeutic Potential
of Nomacopan for Treatment of Trauma
NEW YORK and LONDON, February 28, 2022 - 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 new data showing that clinical outcomes
in U.S. Army trauma patients correlate with complement activation, and that nomacopan significantly improves survival from 30% to 80%
in a clinically relevant preclinical model of traumatic hemorrhage. A full data set is available at https://doi.org/10.22541/au.164423459.98723938/v1.
Clive Richardson, Chief Executive Officer of Akari Therapeutics, commented:
"This very exciting data generated from our collaboration with the U.S. Army supports the development of nomacopan as an organ protective
drug for treatment of severe trauma patients that has the potential to significantly reduce mortality in both a military and civilian
setting. There is now a planned pathway to the clinic, and we look forward to leveraging nomacopan's dual inhibition of the pro-inflammatory
complement C5 and leukotriene LTB4 as a potential treatment for traumatic injury."
Traumatic hemorrhage (TH) is the leading cause of potentially preventable
deaths that occur during the pre-hospital phase of care. Current treatments still largely rely on organ/tissue supportive approaches and
fluid resuscitation, and no effective pharmacological therapeutics are available. Identifying new life- supporting treatment focused on
the interval between point of injury to hospital is a key objective. Military blast injury accounted for 70%-80% of U.S. casualties in
Iraq and Afghanistan, while in the U.S. there are approximately 500,000 civilian trauma hospital discharges a year which are defined as
severe and could benefit from early drug intervention to reduce multi-organ dysfunction. Annual inpatient trauma-related hospital costs
in the U.S. are approximately $30 billion a year1.
An analysis of 54 military trauma patients in Baghdad with blast and
gunshot injury showed that three key markers of complement activation - C5a, C5b9 and Bb - were elevated 300%-600% in the
first eight hours after the traumatic event, compared to healthy controls. In addition, pro-inflammatory C5a and C5b9 plasma levels correlated
with trauma severity, and complement activation correlated with clinical outcomes.
Nomacopan's mode of action may be particularly suited for treatment
of TH as critically it inhibits terminal complement activation (C5a, C5b9) via all three complement pathways (classical, lectin and alternative)
and additionally inhibits leukotriene B4 (LTB4) which is also implicated in exacerbation of TH.
To test the anticipated efficacy of nomacopan, a clinically relevant
pre-clinical model of blast injury and hemorrhagic shock was undertaken by the United States Army Institute of Surgical Research (USAISR).
The addition of nomacopan to damage control resuscitation protocol, significantly inhibited terminal complement activity, decreased local
and systemic inflammatory responses, improved hemodynamics and metabolism, attenuated tissue and organ damage and increased survival (80%
Nomacopan's therapeutic efficacy in this model of TH is likely
a result of the drugs inhibition of multiple inflammatory pathways primarily:
Nomacopan is particularly well suited for pre-hospital use in both
a battlefield/military or ambulance/ civilian setting due to the molecules thermostability and ease of administration. In addition, nomacopan
is fast acting and clears the body within a matter of days is also important in that the optimal window for treatment by inhibiting complement
is likely to be the first 24 hours following TH.
The planned next steps include an extension study following on from
the reported USAISR program. Also, in parallel, a collaboration for a UK observational study with civilian traumatic brain injury patients
to optimize the nomacopan clinical treatment regimen leading to a potential clinical study that could include both military and civilian
1 Source: (DiMaggio et al., 2016, Traumatic injury in the
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
Sukaina Virji/ Maya Bennison
Consilium Strategic Communications