Akari Therapeutics Announces New Preclinical Rheumatoid Arthritis Data and New Clinical Data in Patients with Bullous Pemphig...
September 12 2018 - 7:00AM
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics to treat orphan autoimmune and inflammatory diseases,
today announced results that demonstrate the potential advantages
of Coversin’s unique bifunctional mode-of-action inhibiting both
the complement and leukotriene pathways.
“The combined inhibition of C5 and LTB4 presents a potential
novel therapeutic option. We believe that the bifunctional modality
of Coversin could enable us to target a growing range of orphan
diseases with unmet need where both complement and leukotriene
pathways are believed to be implicated,” commented Clive
Richardson, interim Chief Executive Officer of Akari Therapeutics.
“In the first quarter of 2019 we anticipate announcing Phase II
clinical data in two trials that focus on this bifunctionality: BP,
a blistering skin disease, and atopic keratoconjunctivitis (AKC), a
severe allergic eye condition. The trials will be run in
conjunction with our existing clinical program for the complement
mediated diseases, paroxysmal nocturnal hemoglobinuria (PNH) and
atypical haemolytic syndrome (aHUS).”
Preclinical rheumatoid arthritis model data
Coversin has a unique bifunctional mode-of-action that appears
to independently inhibit C5 and LTB4 by binding tightly both
molecules. In an RA mouse model, performed in the laboratory of
Prof. Andrew D. Luster, M.D., Ph.D., Harvard Medical School, the
effectiveness of Coversin (PASylated), which binds to C5 and LTB4,
is compared to PAS LTB4-Coversin, which binds to LTB4 alone and to
Zileuton, an FDA-approved leukotriene inhibitor. The PASylated
version of Coversin, which is designed to allow weekly subcutaneous
dosing, was chosen in order to help validate this as a treatment
option. The graph linked below shows therapeutic use of the two
distinct PASylated forms of Coversin and Zileuton administered from
day four of the experiment onwards, once arthritic symptoms had
appeared. PAS-Coversin, inhibiting both C5 and LTB4, appeared more
effective than Zileuton and PAS LTB4-Coversin, reversing symptoms
by day 10 in this acute model.
A graph accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/49363afc-ffe4-45fd-9c51-0e4677b32f8e
Dr. Luster stated, “The effect of Coversin (PASYlated) used
therapeutically in our mouse model of rheumatoid arthritis was
impressive with apparent total disease reversal. This highlights
that the novel strategy offered by Coversin of simultaneously
blocking both C5 and LTB4 may make it an effective
anti-inflammatory and offers the potential to provide an
alternative therapy for RA patients who are unresponsive to current
marketed therapies.”
Ex vivo bullous pemphigoid data
In an ex vivo study on four BP patients performed by Dr.
Christian Sadik, M.D., Department of Dermatology, University of
Lubeck, Germany, a major center for the diagnosis and treatment of
pemphigoid diseases, blister fluid from BP patients showed an LTB4
concentration markedly higher than seen in the serum of healthy
patients, likely indicating synthesis of LTB4 in the vicinity of
human blisters1. The presence of C5a in blister fluid implies local
activation of C5. Furthermore, the presence of both activators in
human blister fluid provides support for therapeutic use of
Coversin for treatment of BP.
These new findings support earlier data from a mouse model of
immune complex induced alveolitis where combined inhibition of LTB4
and C5 by Coversin was significantly more effective than inhibiting
either C5 or LTB4 alone2.
REFERENCE:
1Jore M.M., Johnson S., Sheppard D., Barber N.M., Li Y.M., Nunn
M.A., Elmlund H., Lea S.M. (2016) Structural basis for therapeutic
inhibition of complement C5. Nat Struct Biol. 23:378-386.
2Roversi, P. et al. J. Biol. Chem.; published online April 26,
2013.
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 system or leukotrienes or both complement and
leukotrienes together play a primary role in disease progression.
Akari's lead drug candidate Coversin™ is a C5 complement inhibitor
currently being evaluated in paroxysmal nocturnal hemoglobinuria
(PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to
its C5 inhibitory activity, Coversin independently and specifically
inhibits leukotriene B4 (LTB4) activity. Akari is currently
evaluating Coversin in two conditions, the skin and eye diseases
bullous pemphigoid and atopic keratoconjunctivitis, where the dual
action of Coversin on both C5 and LTB4 may be beneficial. Akari is
also developing other tick derived proteins, including long 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 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 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 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 Coversin may not
be as large as expected; risks associate 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
putative shareholder class action and 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 on July 18, 2018. 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 VozzoWestwicke Partners(443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji / Nicholas BrownConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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