Full Press Release Details
Akari Therapeutics Announces New Data from Atopic Keratoconjunctivitis
(AKC) Patients Supporting the Potentially Beneficial Role of Nomacopan as an Inhibitor of both C5 and LTB4 in the Ongoing Phase
NEW YORK and LONDON, October 14, 2019 - 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
The images 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).
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
Mary-Jane Elliott / Sukaina Virji / Nicholas
Consilium Strategic Communications