Akari Therapeutics Announces New Data with Nomacopan from its Surface of the Eye Program
October 25 2021 - 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
announces data highlighting the potential of nomacopan in the
surface of the eye in Allergy, European Journal of Allergy and
Clinical Immunology.
A copy of the article in Allergy, in which some of the data has
been published, is available on the Akari corporate website at
www.akaritx.com and at
https://onlinelibrary.wiley.com/doi/10.1111/all.15128.
Professor Virginia Calder, University College of London (UCL),
Institute of Ophthalmology and study author, commented, “This new
data supports a clear role for leukotriene LTB4 and complement C5
in the inflammatory pathways that drive allergic eye disease and
points to nomacopan eyedrops as a potentially exciting new surface
of the eye treatment option. Current treatments such as steroids
are limited by side effects, variable efficacy and patient comfort.
The role of nomacopan in reducing specific inflammatory mediators
that can be detected in tear fluid as biomarkers is an exciting and
novel feature and opens up the potential for patient targeted
treatment management.”
The article in Allergy summarizes a large body of work
undertaken with University College of London and Moorfields Eye
Hospital. The underlying work demonstrates a clear dose response
effect for nomacopan. The optimal dose of nomacopan showed a
greater reduction in inflammation score than cyclosporin and
dexamethasone compared to control at day 10 (79% [nomacopan], 41%
[cyclosporin], and 73% [dexamethasone]) in an experimental allergic
eye disease model.
The improvement in inflammation seen with nomacopan in this
model is likely to be in part a consequence of the increased
suppression of pro-inflammatory T helper 2 (Th2), Th9 cells and
cytokine IL-9 by nomacopan in comparison to cyclosporin and
dexamethasone. In surface of the eye diseases, Th2 cells are
recognized as the main mediators of allergic responses although
other inflammatory mediators are often also involved.
This model shares many features with vernal keratoconjunctivitis
(VKC), a difficult to treat keratinizing eye disease like AKC. Tear
fluid and tissue samples of VKC patients were analyzed and patients
with the active disease had a similar biomarker profile to that
seen in the allergy model with raised Th cells and IL-9 as well as
increased expression of C5a and BLT1 (LTB4) receptors in
infiltrating cells.
This data complements Akari’s Phase I/II study in severe AKC
patients where nomacopan was comfortable and well tolerated
(Sanchez-Tabernero et al 2021) and where Akari is exploring further
patient targeted work in keratinizing and dry eye diseases.
Akari is now collaborating on a topical mucous membrane
pemphigoid (MMP) program. Over half of MMP patients have a type of
disease that affects the surface of the eye for which there are no
approved treatments. MMP shares a similar pathology with bullous
pemphigoid where Akari has initiated a Phase III study with
nomacopan.
Clive Richardson, Chief Executive Officer of Akari, commented,
“The new surface of the eye data is an important step forward in
our program and highlights the potential benefits of nomacopan’s
differentiated bi-specific mode of action. Taken together with
prior data this collectively points to the more severe form of
these diseases as important clinical targets for nomacopan within
the $6bn+ surface of the eye market.
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, regarding, among other
things, statements related to the offering of securities described
herein, the expected gross proceeds, and the expected closing of
the offering. 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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