Akari Advances Lung Program with Inhaled Nomacopan Focused on Early Treatment of Severe Exacerbations in Lung Diseases
January 26 2022 - 8:30AM
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 further development of a program for the inhaled delivery
of nomacopan to the lung, working with Inhalation Sciences AB to
refine dosing and pharmacokinetics of nomacopan for both dry powder
and nebulized delivery.
Clive Richardson, Chief Executive Officer of Akari Therapeutics,
said, “Accumulating data with nomacopan indicate that the innate
immune response driven by complement and leukotriene pathways could
be critical in determining the severity of the inflammatory
response across a range of diseases including in the lung. Gaining
control of the dysregulation in innate responses by inhibiting C5
and LTB4 with an inhaled form of nomacopan could provide relief
from often life-threatening exacerbations in lung illnesses such as
COPD and severe asthma. We are therefore delighted to be working
with Inhalation Biosciences AB to further develop an inhaled drug
delivery system for nomacopan.”
Data from Akari-sponsored observational studies in exacerbating
chronic obstructive pulmonary disease (COPD) (n=24) and
COVID-pneumonia (n= 72) indicated complement C5 and LTB4 levels
were elevated and the severity of exacerbations in COPD patients
was associated with the initial levels of C5. This points to the
potential for nomacopan, a potent inhibitor of both C5 and LTB4, as
a focused treatment for disease exacerbations across multiple
severe lung disorders, including severe asthma, COPD and
COVID-pneumonia.
Importantly, given both the acute nature of exacerbations which
typically last 2-4 weeks and evidence from the COPD observational
studies that much of the excess C5 and LTB4 is generated in the
lung, a fast-acting inhaled delivery system is likely to be the
preferred delivery route for exacerbating patients. Therefore, to
optimize the potential clinical utility of nomacopan, Akari is now
in development of an inhaled formulation of nomacopan with
Inhalation Sciences AB.
Prior data indicate that nomacopan can be nebulized by
conventional devices and achieve a median particle size suitable
for deep lung delivery while maintaining its inhibitory activity.
In addition, in preclinical models, C5 and LTB4 inhibition by
nomacopan significantly decreases both eosinophils and neutrophils,
key drivers of disease. Furthermore, in multiple preclinical lung
models nomacopan is more effective than C5 and LTB4 inhibition
alone, including leukotriene inhibitors, approved for treatment of
the lung, such as Zileuton.
Akari is focused on developing nomacopan for treating
exacerbations with a patient-friendly inhaled formulation for early
intervention to prevent the potentially serious clinical
consequences. Exacerbations are a significant driver of
hospitalizations and mortality across multiple lung diseases,
including severe asthma and COPD. For example, focusing on only
asthma exacerbations in the U.S., the Centers for Disease Control
and Prevention (CDC) estimates that over 11 million people reported
having at least one asthma exacerbation in the last 12 months.
Furthermore, there were 1.8 million emergency department visits,
nearly 200,000 hospitalizations and about 3,500 deaths.
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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