Akari Presents Results from Two Preclinical Development Programs of Long-Acting PAS-Nomacopan in Geographic Atrophy (GA) Dry Age-Related Macular Degeneration and Nomacopan in Experimental Immune-Mediated Conjunctival Disease (EIC)
May 09 2022 - 7:00AM
Akari Therapeutics, plc (Nasdaq: AKTX), a late-stage biotechnology
company focused on the development of advanced therapies for
autoimmune and inflammatory diseases, presented positive results
from two preclinical studies of its lead asset, investigational
nomacopan, in diseases of the eye at the Association of Research in
Vision and Ophthalmology (ARVO) 2022 Annual Meeting. The two
presentations are available at
www.investor.akaritx.com/news-and-events/presentations.
“There is significant unmet need in ophthalmology, and we are
encouraged by the results of our work so far in the development of
long-acting PAS-nomacopan for geographic atrophy,” said Rachelle
Jacques, President and CEO of Akari Therapeutics. “This will be an
area of focus and investment for Akari as we drive this program
forward.”
Development of long-acting PASylated-nomacopan for
treatment of GA and other retinal diseases
Geographic atrophy (GA) is a chronic progressive degeneration of
the macula, which occurs during late-stage dry age-related macular
degeneration (dAMD). Over time, GA can lead to permanent vision
loss. It is estimated that more than 8 million people worldwide are
affected by GA in AMD and currently there are no approved
treatments.
Studies have indicated that while certain complement inhibitors
slow the progression of GA, they may also promote choroidal
neovascularisation (CNV), which can harm the macula, damage
vision,1,2 and require VEGF rescue therapy.
Leukotriene B4 (LTB4) is a potent leukotactic agent that can
increase retinal vascular endothelial growth factor (VEGF) a key
driver of CNV. Inhibition of LTB4 may decrease the risk of CNV.3
Akari has conducted pre-clinical studies that explore the
importance of the LTB4-VEGF axis and the potential role of
nomacopan’s bispecific inhibition of both C5 and LTB4 in treating
GA/dAMD. In a non-infectious allergic uveitis animal model,
PAS-nomacopan reduced VEGF by more than 50% compared to saline
control, equivalent to the inhibition caused by an anti-VEGF
antibody. In addition, PAS-nomacopan was significantly more
effective in reducing retinal inflammation than the anti-VEGF
antibody.
One of the pre-clinical studies presented at ARVO 2022 used an
industry standard model of laser-induced CNV. Intravitreal (IVT)
PAS-nomacopan injected once during a 16-day treatment period was
compared to a U.S. Food and Drug Administration-approved VEGF
inhibitor for impact on neo-vascularization. The IVT single dose of
PAS-nomacopan significantly reduced CNV (p=0.022) as compared to
saline and was as effective as multiple IVT injections of the VEGF
inhibitor (p=0.019.) Single IVT injection of PAS-nomacopan showed a
trend towards reduced leakage on Day 14 (p = 0.097).
Currently approved therapies for retinal diseases injected
directly into the vitreous cavity are typically administered
monthly. Studies have shown that due to adverse effects (such as an
increase in intraocular pressure [IOP]), discomfort and anxiety,
IVT injection presents a heavy burden on patients. PASylation of
nomacopan has the potential to make it long-lasting in the back of
the eye and may provide a dosing interval that is more attractive
to patients.
Akari is continuing PK and PD work to optimize PAS-nomacopan
with the aim of achieving safety and efficacy in GA, and meeting
patient preferences for less frequent injections
Comparison of topical nomacopan, a dual complement and
LTB4 inhibitor with dexamethasone in downregulating experimental
immune-mediated conjunctival disease (EIC)
Steroid-resistant allergic conjunctivitis, including atopic
keratoconjunctivitis (AKC) and vernal keratoconjunctivitis (VKC),
is difficult to treat and can lead to corneal scarring and vision
loss. Topical or systemic dexamethasone and/or cyclosporin A (CsA)
is often required, however dexamethasone may be associated with
adverse reactions, including increased IOP.
Topical administration of nomacopan, a therapeutic protein, was
recently shown to be effective at attenuating inflammation in a
model of experimental immune-mediated conjunctivitis (EIC). The aim
of the study presented at ARVO 2022 was to compare the
anti-inflammatory effects of nomacopan with topical
dexamethasone.
IL-9 expressing mast cells and CD4+T cells are upregulated
during ovalbumin (OVA)-induced EIC.
In the preclinical study presented at ARVO 2022, nomacopan
preferentially downregulated conjunctival Th2 IL9 producing, Th2
and Th9 CD4+T-cells and nomacopan, dexamethasone and cyclosporinA
all effectively decreased Th2 and Th9 cells in draining lymphnodes
(dLNs). These findings support use of topical nomacopan to treat
allergic eye diseases including VKC and AKC.
References:
- Liao DS, et al. Ophthalmology. 2020 Feb;127(2)
- Jaffe GJ et al. Ophthalmology. 2021 Apr;128(4)
- Sasaki F et al. JCI Insight. 2018 Sep 20;3(18)
About Akari TherapeuticsAkari Therapeutics, plc
(Nasdaq: AKTX) is a biotechnology company focused on developing
advanced therapies for autoimmune and inflammatory diseases.
Akari's lead asset, investigational nomacopan, is a bispecific
recombinant inhibitor of C5 complement activation and leukotriene
B4 (LTB4) activity. The Akari pipeline includes two late-stage
programs for bullous pemphigoid (BP) and thrombotic microangiopathy
(TMA), as well as earlier stage research and development programs
in eye and lung diseases with significant unmet need. For more
information about Akari, please visit akaritx.com.
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. 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 there; difficulties enrolling patients in our
clinical trials; 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 departure of our former Chief Executive
Officers and other executive officers; 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 VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji/ Maya BennisonConsilium Strategic
CommunicationsAkari@consilium-comms.com
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