Akari Therapeutics announces new data demonstrating synergistic benefits of nomacopan’s bifunctional C5 and LTB4 inhibitory...
August 09 2019 - 8:30AM
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 announced new preclinical and human
data demonstrating the potential benefits of the dual inhibition of
complement (C5) and leukotriene (LTB4) pathways by nomacopan for
the treatment of pemphigoid disease (PD).
Bullous Pemphigoid (BP) is a severe orphan autoimmune
inflammatory skin disease with an estimated prevalence of 18 per
100,000 in the U.S. and Europe. BP has a relapsing course over
several years and is currently treated primarily with steroids and
immunosuppressants, which bring with them well-known side effects,
especially in the elderly population affected by BP.
In a murine model of pemphigoid diseases, nomacopan, which
inhibits both C5 and LTB4, and L-nomacopan, which inhibits only
LTB4, were shown to both significantly attenuate disease. However,
nomacopan was shown to reduce disease more effectively than
L-nomacopan highlighted by a reduction in peak disease activity of
75% and 60%, respectively. The results demonstrate the synergistic
inhibition of C5 and LTB4 in the therapeutic efficacy of nomacopan
in this model.
The joint role of C5 and LTB4 in BP is further supported by data
from BP patients which highlight the role of both inflammatory
mediators in disease progression. C5a and LTB4 are present in
patients’ (n = 10) blister fluid in quantities that induce in vitro
recruitment of granulocytes which are considered necessary for
disease progression. Furthermore, the number of cells expressing C5
and LTB4 G-protein coupled receptors is significantly increased in
perilesional skin compared to healthy control skin supporting the
view that selectively disrupting the recruitment of granulocytes
into the skin by inhibiting both C5 and LTB4 may be key to treating
pemphigoid diseases.
Initial data (announced on April 23, 2019) from the first three
BP patients in Akari’s ongoing Phase II clinical trial in patients
with BP demonstrated a rapid reduction in BP Disease Area Index
(BPDAI) score and blistering. There were no reported drug related
serious adverse events for the BP patients, which is comparable to
treatment data from other patients systemically treated with
nomacopan for a total of approximately 20 cumulative
patient-years.
Further data on BP patients treated as part of the Company’s
ongoing Phase II study will be presented at the 28th European
Academy of Dermatology and Venereology (EADV) Congress, Madrid on
October 10, 2019.
“This unique bifunctional pharmacological
activity highlights nomacopan as a potentially highly effective
therapeutic compound. The results support the concept that the
parallel targeting of C5 and LTB4 is therapeutically superior to
targeting only one of these mediators because it may overcome
pathway redundancy and counter-regulatory pathways. This principle
may not only apply to pemphigoid diseases but also to other
antibody-mediated diseases, which often exhibit a spatiotemporal
coincidence of C5 and LTB4 activation in their pathogenesis,”
commented Dr. Christian Sadik from University of Lubeck,
Germany.
Miles Nunn, Chief Scientific Officer of Akari
Therapeutics, said, “Both C5a and LTB4, which are inhibited by
nomacopan, have central roles in the recruitment and activation of
granulocytes, and in BP are responsible for the formation of
blisters at sites of autoantibody deposition. The encouraging data
of Dr. Sadik and colleagues provides further support for the
potential for the combined inhibition of C5 and LTB4 by nomacopan
to provide a major therapeutic advantage in BP and other autoimmune
diseases. “
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)
activity. 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.
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 therefrom;
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 informationInvestor Contact:
Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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