Full Press Release Details
Akari Presents Results from Two Preclinical
Development Programs of Long-Acting PAS-Nomacopan in Geographic Atropy (GA) Dry Age-Related Macular Degeneration and Nomacopan in Experimental
Immune-Mediated Conjunctival Disease (EIC)
NEW YORK and LONDON, May 9, 2022 (GLOBE
NEWSWIRE) - 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
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-clincal studies presented at ARVO 2022 used an industry
standard model of laser-induced CNV. Intraveitreal (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
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
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 cyclosporin A all effectively decreased
Th2 and Th9 cells in draining lymphnodes (dLNs). These findings support use of topical nomacopan to treat allergic eye diseases including
About Akari Therapeutics
Akari 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 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 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
Sukaina Virji/ Maya Bennison
Consilium Strategic Communications