Akari Therapeutics Announces Further Clinical Trial Progress Using Nomacopan to Treat COVID-19 Pneumonia
October 06 2020 - 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, announces further progress in its COVID-19
pneumonia program with nomacopan in the U.S. and Brazil.
Clive Richardson, Chief Executive Officer of Akari Therapeutics
said, “We are pleased to be able to report continued progress with
our COVID-19 pneumonia program. In addition to its potential to
treat COVID-19 pneumonia, we believe nomacopan’s dual complement
and leukotriene inhibition has applicability in a range of other
severe lung inflammatory conditions which we are exploring and like
COVID-pneumonia have proven difficult to treat due to the
involvement of multiple inflammatory pathways.”
COVID-19 pneumonia is believed to be a major cause of death in
patients with COVID-19 and despite improvements in standard of
care, remains difficult to treat. Accumulating data across a range
of clinical studies in patients with COVID-19 pneumonia continues
to point at the central role of complement C5a and C5b9 as well as
neutrophil accumulation in the lung leading to severe inflammation
and dramatic reductions in the delivery of blood through the
capillary bed of the lung and ultimately other organs. Nomacopan
has been shown to inhibit all these pathways directly; by binding
C5, nomacopan inhibits production of C5a and C5b9 which have
inflammatory and prothrombotic effects, and by preventing LTB4 from
interacting with its cell surface receptors nomacopan may directly
inhibit the migration of neutrophils to the lung and subsequent
damaging cytokine release.
The Company’s initial proof of principle studies have
demonstrated that the 45mg standard dose of nomacopan can be used
to treat patients with COVID-19 pneumonia without the need for
up-dosing. The studies showed rapid onset of action of nomacopan,
as well as no reported adverse safety signals in this fragile
patient group. In addition, the Company believes that the
relatively fast offset of nomacopan activity once dosing has been
discontinued is a beneficial safety feature potentially allowing
early patient discharge from hospital without the risk of long term
immunosuppression. Furthermore, nomacopan was dosed alongside both
antivirals and steroids (current standard of care) and may have an
additive effect as steroids do not directly inhibit complement
activation or LTB4.
Both studies in the U.S. and Brazil are double blind randomized
clinical studies (2:1 in favor of nomacopan treatment) of over 60
patients each, with a primary endpoint of time to oxygen
normalization and hospital discharge. The secondary endpoints will
include the need for intubation and mortality. Patients will
receive either a daily subcutaneous dose of nomacopan and standard
of care or placebo and standard of care. Treatment is for up to 14
days, with study monitoring and completion after two months.
Akari Therapeutics has been invited to present an update on its
COVID-19 pneumonia program at the 4th Annual Complement-Based Drug
Development Summit 2020 on October 15, 2020. The presentation will
explore the association between COVID-19 morbidity, complement
activation and LTB4, as well as the current trials with nomacopan
in patients with COVID-19 pneumonia. Akari’s presentation at the
conference will be available by visiting ‘Events’ in the Investor
Relations section on the Company’s website at www.akaritx.com.
About Akari TherapeuticsAkari 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.
Cautionary Note Regarding Forward-Looking
StatementsCertain statements in this press release
constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. You should not
place undue reliance upon the Company’s forward looking statements.
Except as required by law, the Company undertakes no obligation to
revise or update any forward-looking statements in order to reflect
any event or circumstance that may arise after the date of this
press release. 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; our ability to enter into collaborative,
licensing, and other commercial relationships and on terms
commercially reasonable to us; 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 impact of the outbreak of
coronavirus; 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.
Investor Contact:
Peter VozzoWestwicke+1 (443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Lizzie SeeleyConsilium Strategic
Communications+44 (0)20 3709 5700Akari@consilium-comms.com
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