Full Press Release Details
Akari Therapeutics Announces Preclinical
Ophthalmic Data Showing Nomacopan Reduces Both Vascular Endothelial Growth Factor (VEGF) and Retinal Inflammation Supporting Nomacopan
as a Potential Treatment Option for Back-of-the-Eye Diseases
NEW YORK and LONDON, January 27, 2020- Akari Therapeutics,
Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat autoimmune and inflammatory diseases
where the complement and/or leukotriene systems are implicated, announces new preclinical data indicating that nomacopan significantly
reduced both retinal inflammation and intraocular VEGF.
Treatment of back-of-the-eye diseases, including angiogenic
ocular diseases with new blood vessel growth such as diabetic retinopathy and wet age-related macular degeneration (AMD), is a
multi-billion dollar market. VEGF promotes angiogenesis in these latter conditions, and inhibition of VEGF with antibodies such
as Lucentis and antagonists such as Macugen and Eyelea form
the mainstay of treatment of wet AMD. In contrast, complement inhibitors are being explored as a treatment for dry AMD.
the successful use of VEGF inhibitors, many patients with AMD and other back-of-the-eye diseases remain sub-optimally treated,"
said Professor Virginia Calder, University College of London (UCL), Institute of Ophthalmology. "This
reflects the complex natural history and pathology of these retinal diseases. An agent such as nomacopan that appears to combine
anti-inflammatory activity with VEGF and complement inhibition has the potential to improve treatment options, highlighting the
importance of these pathways and the degree to which their dysregulation is implicated in different sight-threatening conditions."
Professor Calder and colleagues at UCL have undertaken new work
comparing the therapeutic efficacy of nomacopan, PAS-nomacopan, and a monoclonal anti-VEGF antibody all administered intravitreally.
Their work utilized an established 26-day model of severe experimental autoimmune uveitis (EAU) in mice which results in elevated
VEGF and retinal inflammation mediated by influx of lymphocytes which thereby mimics the pathology seen in several back-of the
eye diseases. Drug treatments were administered on day 15 once disease was established and ongoing.
PAS-nomacopan was found to reduce intraocular VEGF levels by
as much as the anti-VEGF antibody with 74% (p=0.04) and 68% (p=0.05) reductions respectively, compared to saline control. Furthermore,
while clinically assessed inflammation increased in both the control and anti-VEGF groups by 49% and 33%, respectively, PAS-nomacopan
treatment showed a 9% reduction in inflammation assessed by retinal fundoscopy (p=0.02), supporting nomacopan's therapeutic
activity across multiple pathogenic pathways.
PAS-nomacopan, which has a very large functional molecular weight
of 670kDa, due to use of the PASylationTM technology (Kuhn et al. 20161), was more effective than nomacopan
(17kDa) in reducing both VEGF levels and inflammation, probably reflecting longer residency time of PAS-nomacopan in the eye.
The rationale for using nomacopan as a treatment for the back-of-the-eye
was initiated by the discovery that cell-activating receptors (C5aR1 and BLT1) that bind to complement C5a and LTB4 are expressed
by retinal inflammatory cells in the back of the eye. Nomacopan inhibits C5 activation preventing formation of C5a and captures
LTB4, and thereby has the potential to inhibit C5a and LTB4 signalling via the receptors identified in the retina.
Furthermore, as previously reported in an EAU model (April 26,
2019), nomacopan significantly reduced inflammatory markers such as the cytokine IL-17 together with clinical and histological
inflammation. Nomacopan's activity appeared to be equivalent to potent corticosteroids, the standard of care treatment for
acute posterior non-infective uveitis.
These results suggest the potential for nomacopan as a first-line
treatment for multiple back-of-the-eye diseases in that the single drug has now been demonstrated to mitigate three pathways implicated
in uveal, macular and retinal diseases:
Wynne Weston-Davies, Medical Director, Akari Therapeutics, said,
"We have an ongoing Phase II trial in atopic keratoconjunctivitis (a surface of the eye disease) with nomacopan and are pleased
to report new encouraging pre-clinical data in the back of the eye with the differentiated long-acting PAS-nomacopan. We are now
actively exploring other pre-clinical models in diseases such as AMD and how best to develop these findings in the clinic where
there remains a significant unmet need."
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). Nomacopan is currently being clinically evaluated in four indications: bullous pemphigoid (BP),
atopic keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes
that the dual action of nomacopan on both C5 and LTB4 may be beneficial in AKC and BP. Akari is also developing other tick derived
proteins, including longer acting versions.
1Nomacopan, formerly
Coversin, accepted as International Non-proprietary Name by World Health Organization.
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, 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; our ability to enter into collaborative, licensing, and other commercial relationships and on
terms commercially reasonable to us; 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; 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
Sukaina Virji / Nicholas Brown / Lizzie Seeley
Consilium Strategic Communications