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 that positive data from an
ongoing bullous pemphigoid (BP) Phase II clinical trial will be
presented at the 28th European Academy of Dermatology and
Venereology (EADV) Congress in Madrid, Spain. The presentation will
be posted onto Akari’s website at Akari Therapeutics.
BP is a severe orphan autoimmune inflammatory blistering skin
disease with no approved treatments in the U.S. and Europe. The
disease is primarily treated with steroids and immunosuppressants
which bring with them well known side effects and an approximately
three-fold increase in mortality in the elderly BP patient
population.
“The positive safety profile and rapid response to treatment
with nomacopan, even with no steroid co-medication, supports a
treatment strategy that could see steroid use rapidly reduced in BP
patients,” commented Clive Richardson, Chief Executive Officer
of Akari Therapeutics. “As a result of this encouraging data,
we now plan to develop our pivotal study design in conjunction with
the FDA and EMA. We intend to begin the pivotal study in H2 2020,
positioning nomacopan as potentially a first-in-class treatment for
this severe and debilitating disease.”
In patients with BP there is evidence that both terminal
complement activation (via complement component C5) and the lipid
mediator leukotriene B4 (LTB4) have a central role in driving the
disease. Ex vivo data in BP patients, recently published in the
August 2019 edition of JCI Insight [LINK] showed a pronounced
accumulation of LTB4 and C5 and its activation products in the
inflamed skin of BP disease patients underlying the rationale for
treatment with nomacopan which is a bifunctional inhibitor of both
C5 and LTB4.
The Phase II trial, which includes up to nine mild-to-moderate
bullous pemphigoid patients, is a six-week (42 days of nomacopan
dosing) open-label single-arm study evaluating safety and efficacy.
Patients entering the trial were typically on the topical steroid
mometasone which was stopped by day 21. The main efficacy measure
is the Bullous Pemphigoid Disease Area Index (BPDAI) which along
with blistering is a frequently used evaluation of the extent and
severity of this skin disease.
Results showed that nomacopan, dosed daily subcutaneously, was
well tolerated in six elderly patients (>55 years), and that
there were no reported drug-related serious adverse events. This
safety profile mirrors over 20 cumulative patient-years of data
from patients treated with nomacopan across four other conditions
in clinical development where no drug-related serious adverse
events have been observed.
Four of the six patients were classified as at the upper limit
of moderate BP. Moderate to severe patients represent about
two-thirds of BP patients and are likely to benefit most from the
potential to reduce or avoid steroids. These patients, who showed
only a minor improvement on mometasone prior to initiation on
nomacopan, saw a mean 41% and 63% decline in BPDAI score at day 21
and 42, respectively, and a 59% and 68% decline in blister score at
day 21 and 42, respectively (see graph below of four moderate
patients). One of the moderate patients had a flare up post day-28,
which is not an uncommon on treatment as BP is a recurrent
autoimmune disease.
Of the two mild patients, one patient showed a 100% decline in
blisters by Day 21, sustained to day 42, and a decline in BPDAI
score of 55% and 45% by day 21 and day 42, respectively. The other
patient showed no response either on nomacopan or when switched to
rescue steroids at day 28. This patient entered the trial after
disease relapse while on steroid treatment.
Three of the patients who responded received mometasone steroids
tapered to zero by day 21. Two other patients were on nomacopan
only, with no steroids, and showed a similar beneficial response
with a mean 39% and 79% drop in BPDAI activity at day 21 and day
42, respectively, and a 57% and 93% drop in blisters at day 21 and
42, respectively.
Dr. Christian Sadik, lead investigator from the Department of
Dermatology, University of Lubeck, Germany commented, “The Phase II
trial using nomacopan showed rapid onset of clinical improvement in
five of six patients, supressing BP both when used alone and in
combination with small amounts of topical mometasone. These data
show that nomacopan may be effective as a monotherapy, and also
show that nomacopan may facilitate the treatment of BP in
outpatient settings and minimise the use of steroids that cause
clinical complications.”
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
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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/fdb2ed91-9803-4a34-afcd-f1e4c806bff4
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