Akari Therapeutics Announces New Data from Atopic Keratoconjunctivitis (AKC) Patients Supporting the Potentially Beneficial R...
October 14 2019 - 8:37AM
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, announces new data supporting the
independent roles that the complement and leukotriene pathways may
have in severe eye surface inflammation. These data support the
potential use of nomacopan, which inhibits both LTB4 and C5, as a
treatment for patients with atopic keratoconjunctivitis
(AKC).
Immunofluorescence imaging of conjunctival tissue taken from AKC
patients by Professor Virginia Calder and her team at the UCL
Institute of Ophthalmology London demonstrated expression of
complement C5a receptor 1 (C5aR1) and the LTB4 receptor BLT1 within
conjunctiva. The conjunctiva covers part of the surface of the eye
and lines the eyelids, among other roles it lubricates the eye and
acts as a barrier to infection. Whereas the role of leukotriene
LTB4 in allergic eye surface inflammation and contact lens
intolerance is well-established with a 20-fold increase shown in a
study by Professor Mark Wilcox, School of Optometry and Vision
Science, University of New South Wales, the role of complement in
allergic eye disease has been less well understood. This new work
shows that leukotriene BLT1 receptors are closely associated with
mucus secreting goblet cells within the conjunctival epithelium
whereas the complement C5a receptors are expressed in the deeper
stromal layers of the conjunctiva. The different cellular
distribution suggests potential independent roles for both the
complement and leukotriene cascades in severe eye surface
inflammation, hence nomacopan may be able to reduce inflammation in
multiple layers and provide a unique treatment benefit.
Professor Calder said, “These findings are significant and tie
in well with our previous work showing that nomacopan, which blocks
both complement C5 and LTB4 activity, is likely to have a strong
anti-inflammatory effect and be more effective than other treatment
options given the heterogenous inflammatory environment in the
eye.”
The images linked below show that the C5aR1 receptor (staining
red) and the BLT1 receptor (staining green) are separately located
in a section taken from an inflamed conjunctival papilla at X200
(A) and X400 (B) magnification. Section B shows that CD4 +T cells
(white) are in close proximity to both receptors, which provides a
potential link to the decrease in CD4 positive T cells seen in mice
with experimental allergic conjunctivitis treated with nomacopan
eye drops. Section C shows conventional hematoxylin and eosin (HE)
stained section from same papilla for morphologic orientation
(nuclei are purple and cytoplasm/extracellular matrix are
pink).
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/b916b775-96ba-4e64-9099-bf9d99176f41
Recruitment into Part B of TRACKER, Akari’s Phase I/II clinical
trial of topical nomacopan in AKC is ongoing and an interim data
readout is expected at the end 2019. This follows on from
completion of Part A of TRACKER which confirmed the safety and
comfort of the drops in this first-in-eye study, but also saw
within 2 months a strong efficacy signal with a 55% mean
improvement in total clinical score (comprising signs and symptoms)
in severe AKC patients receiving nomacopan in addition to standard
of care cyclosporin. Cyclosporin is the standard of care treatment
and Patients in Part A had received cyclosporin for at least three
months prior to treatment with nomacopan.
Clive Richardson, Chief Executive Officer of Akari, said, “This
new data provides a strong scientific rationale for our approach of
dual targeting the complement and leukotriene systems in this case
in combating epithelial inflammation in the eye, the benefit of
which is evidenced in our promising clinical response data from
Part A of the AKC study. The dual functionality of nomacopan has
also been shown in several other diseases including bullous
pemphigoid, rheumatoid arthritis and immune-complex lung disease
demonstrating the broad potential of this unique treatment
approach.”
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
(Coversin), is a C5 complement inhibitor that also independently
and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan
(Coversin) is currently being clinically evaluated in four
indications: bullous pemphigoid (BP), atopic keratoconjunctivitis
(AKC), thrombotic microangiopathy, or TMA, and paroxysmal nocturnal
hemoglobinuria (PNH). Akari believes that the dual action of
Nomacopan (Coversin) on both C5 and LTB4 may be 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 (Coversin) 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 (Coversin) 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 (Coversin) 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
(Coversin) may not be as large as expected; risks associated with
the departure of our former Chief Executive Officers and other
executive officers; risks related to material weaknesses in our
internal controls over financial reporting and risks relating to
the ineffectiveness of our disclosure controls and procedures;
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 information
Investor Contact:Peter Vozzo Westwicke Partners (443) 213-0505
peter.vozzo@westwicke.com
Media Contact:Mary-Jane Elliott / Sukaina
Virji / Nicholas Brown Consilium Strategic Communications
+44 (0)20 3709 5700 Akari@consilium-comms.com
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