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, today announces the publication of the
results of a two-year research collaboration with the University
College of London (UCL) Institute of Ophthalmology. The results
showed that the therapeutic intravitreal (IVT) administration of
long-acting nomacopan mitigated both the severity and progress of
retinal damage in two models of autoimmune uveitis, a severe
inflammatory eye disease where steroids are the primary treatment
option. In addition, results showed the presence of inflammatory
cells expressing both complement C5 and LTB4 receptors in retinal
tissue from donor patients with uveitis as compared to
healthy donor eyes.
These data point to the potential importance of LTB4 in the
development of inflammatory retinal diseases which potentially
include proliferative age-related macular degeneration (wet AMD),
diabetic retinopathy, diabetic macular oedema and autoimmune
uveitis.
While complement C5 activation has previously been shown to have
a causative role in late stage EAU1,2, the authors of the paper
focused on the less well understood contribution of LTB4 to uveitis
disease pathology.
Key findings were that IVT administration of the long-acting
engineered form of nomacopan that only binds to LTB4 was at least
as effective as the steroid dexamethasone in reducing retinal
inflammation. Nomacopan significantly decreased proliferation,
differentiation and infiltration of Th17 and Th1/17 effector CD43 T
cells and reduced activated macrophage cell populations, each of
which is reported as having a causative role in uveitis disease
pathology.
Intravitreal LTB4 and C5a was elevated in response to EAU and
the level rose from initiation until the disease peaked at Day 21.
Few LTB4 or C5a receptors were detected in healthy human donor
eyes, but significant numbers of infiltrating cells displaying
these receptors were detected in uveitic eyes of EAU mice and in
post-mortem retinal sections from patients with uveitis, supporting
the likely role of LTB4 and C5 in the disease pathology.
Corticosteroids such as dexamethasone are the current standard
of care for uveitis but may be associated with significant steroid
related side effects such as increased risk of raised intraocular
pressure, cataract formation, keratopathy and macular oedema, hence
an equally effective and safer alternative treatment would be well
received.
In conclusion, the new data highlight the likely importance of
LTB4 in the aetiology of retinal inflammation and effectiveness of
nomacopan’s LTB4 inhibitory activity in the model of uveitis. The
data also show that inhibition of LTB4 decreases Th17 effector cell
differentiation and proliferation and activation of macrophages,
which, along with complement inhibition, may not only be relevant
in uveitis but also for other autoimmune diseases for which
nomacopan is being developed, including bullous pemphigoid.
Dr. Miles Nunn, Chief Scientific Officer of Akari Therapeutics,
said, “This study confirms the important role of LTB4 in uveitis
and likely other autoimmune diseases by downregulating
granulocytes, T cells and macrophages that may cause and direct
inflammation and tissue damage. Complement dysregulation is
implicated in several back of the eye diseases including dry AMD
and as such the combined inhibition of C5 and LTB4 offers a
potential unique treatment alternative.”
Professor Virginia Calder of UCL institute of Ophthalmology
said, “There is a need for safer, localized treatments for patients
with uveitis since steroids are especially problematic for the eye.
These new findings point to LTB4 playing a key role during disease,
and the anti-inflammatory effect of nomacopan in EAU demonstrates
an exciting and novel potential therapeutic option.”
1 D. A. Copland, K. Hussain, S. Baalasubramanian, T. R. Hughes,
B. P. Morgan, H. Xu, A. D. Dick and L. B. Nicholson. Systemic and
local anti-C5 therapy reduces the disease severity in experimental
autoimmune uveoretinitis. British Society for Immunology, Clinical
and Experimental Immunology, 159: 303–314. 2009.
2 S. Reinehr, S.C. Gomes, C.J. Gassel, M. Ali Asaad, Gesa Stute,
M. Schargus, H. Burkhard Dick, S.C. Joachim. Intravitreal Therapy
Against the Complement Factor C5 Prevents Retinal Degeneration in
an Experimental Autoimmune Glaucoma Model. Frontiers in
Pharmacology. December 2019, vol 10, article 1381.
3 Eskandarpour M, Chen YH, Nunn MA, Coupland SE, Weston-Davies
W, Calder VL. Leukotriene B4 (LTB4) and its receptor in
Experimental Autoimmune Uveitis (EAU) and in human retinal tissues:
clinical severity and LTB4-dependence of retinal Th17 cells. Am J
Pathol. 2020 Nov 4:S0002-9440(20)30491-0. doi:
10.1016/j.ajpath.2020.10.010. Epub ahead of print. PMID:
33159884.
About Akari TherapeuticsAkari 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.
Cautionary Note Regarding Forward-Looking
StatementsCertain statements in this press release
constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. You should not
place undue reliance upon the Company’s forward looking statements.
Except as required by law, the Company undertakes no obligation to
revise or update any forward-looking statements in order to reflect
any event or circumstance that may arise after the date of this
press release. 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 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 may not be as large as
expected; risks associated with the COVID-19 pandemic; 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.
Investor Contact:Peter VozzoWestwicke+1 (443)
213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji / Lizzie
SeeleyConsilium Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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