Akari Therapeutics’ Nomacopan Demonstrates Positive Early Safety and Efficacy in Phase I/II Clinical Study in Moderate-to-S...
June 19 2019 - 6:39AM
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 positive results for Part A
of TRACKER, a Phase I/II clinical trial evaluating the safety and
efficacy of topical nomacopan in moderate to severe atopic
keratoconjunctivitis (AKC).
AKC is a serious corneal and eye surface disease which
frequently progresses to visual impairment. Currently, there are no
approved drugs and current standard of care is based on topical and
systemic immunosuppression. The current treatments are considered
sub-optimal because they frequently fail to prevent progression of
the disease and the topical drops are often associated with a high
incidence of pain and irritation.
“The results from the first three patients included in
Part A exceeded our expectations. The rapid response and the
overall reduction of 55% in the composite clinical score by Day 56
despite the patients starting treatment while on long term maximal
cyclosporin, is very encouraging in AKC which has no approved
therapy and limited effective treatment options,” said Clive
Richardson, Interim Chief Executive Officer of Akari Therapeutics.
“AKC is often associated with severe dry eye disease (DED) and as
such may be a potential gateway into the broader and significant
multi-billion dry eye disease market”.
This early data in AKC further supports the therapeutic efficacy
of nomacopan, a dual acting complement C5 and LTB4 inhibitor,
observed in initial clinical data for the treatment of bullous
pemphigoid and thrombotic microangiopathy after haematopoietic stem
cell transplantation which, like AKC, have no approved
treatments.
In Part A of the Phase I/II study, three patients were treated
with twice daily nomacopan eye drops in addition to standard of
care for up to 56 days in order to establish the safety and
tolerability of the drops in preparation for Part B, a randomized,
double-masked placebo-controlled comparison in 16 patients. Of the
three patients enrolled in the study, two completed 56 days of
treatment and one completed 14 days and then withdrew for reasons
unrelated to the study treatment. All patients, who were on the
moderate/severe end of the AKC spectrum, had been on maximal
topical cyclosporin, the standard of care, for at least three
months prior to entry and continued on it during the trial. In the
event of further disease progression, the next incremental step
would normally have been systemic immunosuppression.
The drops were found to be comfortable and well-tolerated
throughout the trial for all three patients. There were no serious
adverse events (SAE) reported. On that basis, the independent
safety committee has now given permission for the trial to proceed
to Part B and recruitment has commenced.
The secondary objective of the study was to determine efficacy,
assessed by a standard composite scoring system [Akpek E.K. et al.
Ophthalmology 2004 (III,3)] consisting of five symptoms which were
patient reported, and six signs of ocular damage which were graded
by the clinician on a direct slit-lamp examination of the eye. Each
sign or symptom was graded 0 to 3, where 0 = normal or absent and 3
is the most severe, such that with 11 measures the overall maximum
severity score was 33.
There was an overall improvement in clinical score of 55%
composed of an improvement in symptoms of 62% and signs of 52% by
Day 56. Symptoms consist of subjective occurrences such as
discomfort and itching. Signs are objective manifestations of
disease, such as conjunctival redness, growth of new blood vessels
into the cornea and microscopic damage to the corneal surface
(punctate keratitis).
In addition, post-instillation comfort was reported by patients
as excellent with high levels of acceptance of eye drops, which
were described as comfortable and refreshing.
Mr Sajjad Ahmad, consultant ophthalmic surgeon at Moorfields Eye
Hospital and the Principal Investigator in this study said: “Part A
of the trial shows that nomacopan is well tolerated and preliminary
efficacy data is encouraging. We are hopeful that nomacopan will
fill an unmet clinical need in ocular surface inflammation.”
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 Partners(443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/437749b1-3857-4c16-a1cc-8efaf4aa2cdb
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