Akari Therapeutics Presents New Data Revealing Potential Mechanism of Action Driving Serious Exacerbations Across Lung Disorders
02 December 2021 - 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
announces data from observational studies in COVID pneumonia and
chronic obstructive pulmonary disease (COPD) that highlight the
potential role of complement and leukotriene hyperactivity in
driving life threatening disease exacerbations and therefore a
potential therapeutic role for nomacopan.
An observational study sponsored by Akari on COVID pneumonia
undertaken at Portsmouth Hospitals University NHS Trust was
reported at the recent British Thoracic Society Annual Meeting
November 24-26, 2021 (1). Plasma levels of C5a, C5b9 and LTB4 in
COVID pneumonia patients were elevated compared with control
patients and increased with disease severity. In addition, the
levels of C5a (p = 0.001) and C5b9 (p = 0.019). which are potential
biomarkers for disease progression, rose significantly in patients
that worsened (i.e., those requiring invasive mechanical
ventilation or who died).
These findings align with a prior, separate Akari-sponsored
observation study in COPD patients (2) that demonstrated that
exacerbating patients have elevated C5a in sputum but not in serum
and that the level of C5a was correlated with the duration/severity
of the exacerbations (p=0.01). In exacerbations of COPD,
Leukotriene B4 (LTB4) is also found in the sputum (3). All three of
these inflammatory mediators, LTB4, C5a and C5b9 are inhibited by
nomacopan.
Akari is targeting lung diseases such as asthma, COPD and COVID
pneumonia where in certain patients, a hyperreactive response to
external agents triggers a severe exacerbation. For example, it is
estimated that 14% of COPD patients have severe annual
exacerbations associated with hospitalization and increased
mortality (4).
Complement (C5 and its by products C5a and C5b9) and leukotriene
(LTB4) are key inflammatory mediators which through their
inhibition by nomacopan may prevent disease progression. Their
combined inhibition has been shown in several lung disease models
to be more effective than inhibiting either LTB4 or C5 alone.
Leukotriene inhibition is an established treatment for severe
asthma and complement hyperactivity is increasingly associated with
severe lung inflammation. Importantly, the observational data
indicate that the inflammatory response may be driven by rising
complement and leukotriene levels directly in the lung, indicating
that an inhaled form of nomacopan may potentially be the most
effective route of administration. Akari has demonstrated full
activity and potential for deep delivery to the lung with a
nebulized inhaled form of nomacopan.
Akari is investigating the pharmacokinetics of inhaled nomacopan
in the lung and a proof of principle study in exacerbating COPD
patients to further evaluate the impact of inhibiting C5 and LTB4
with nomacopan.
In addition, the COVID pneumonia observational findings are
being further evaluated to explore the potential role of biomarkers
in identifying the most appropriate COVID pneumonia patients to be
treated with nomacopan.
Professor Tim Higenbottam DSc, MA, MD, FRCP, FPPM commented,
“Lung exacerbations are a major problem yet to be adequately
treated. There is growing evidence that these exacerbations are
driven by both C5 and LTB4 which is important in their potential
role as biomarkers of an excessive innate immune response and as a
pointer of possible treatment. Nomacopan represents a potential new
therapeutic option which could have applicability across COPD,
severe Asthma, and COVID pneumonia where an over-reactive innate
immune response puts patients at risk of a life-threatening
hyperinflammatory response.”
References:
- Wiffen L, Brown T, Chauhan, M et
al., Measures of inflammation, complement activation and
coagulation in patients with COVID-19. A38 Thorax 2021; 76 (Suppl
2) : A1 – A205.
- Westwood J-P, Mackay AJ, Donaldson
G….Wedzicha JA. The role of complement activation in COPD
exacerbation recovery. ERJ Open Res 2016; 2: 00027-2016 | DOI:
10.1183/23120541.00027-2016.
- Drozdovszky O, Barta I, Antus B.
Sputum Eicosanoid Profiling in Exacerbations of Chronic Obstructive
Pulmonary Disease. Respiration 2014;87:408–415. DOI:
10.1159/000358099.
- Wise RA, Calverley PMA, Carter K,.
et al., Seasonal variations in exacerbations and deaths in patients
with COPD during the TIO SPIR© trial. Int J COPD. 2018: 13;
605-616.
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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