Akari Therapeutics Receives Positive EMA Opinion on Orphan Designation for Nomacopan for Bullous Pemphigoid
May 21 2020 - 11:32AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company
focused on innovative therapeutics to treat orphan autoimmune and
inflammatory diseases where the complement (C5) and/or leukotriene
(LTB4) systems are implicated, today announced that the European
Medicines Agency (EMA) has issued a positive opinion on Akari’s
application for orphan designation of nomacopan for the treatment
of bullous pemphigoid (BP).
Akari recently announced the successful
completion of a Phase II study in BP where the combined therapeutic
role of both complement (C5) and leukotriene (LTB4) has been well
documented. The study achieved the primary endpoint of no reported
drug-related serious adverse events and main efficacy endpoints
with 7 of the 9 treated patients showing a rapid and clinically
significant reduction in Bullous Pemphigoid Disease Area Index
(BPDAI) score. In September 2019, nomacopan received Orphan Drug
designation from the U.S. Food and Drug Administration (FDA) for
BP.
The Company believes nomacopan’s dual inhibition
of C5 and LTB4 also makes the drug potentially well suited for the
treatment of patients with COVID-19 pneumonia and related COVID
diseases. In pre-clinical lung inflammation models including a
model of viral induced lung inflammation, nomacopan (formerly known
as coversin) showed significant reductions in key lung inflammatory
markers such as neutrophils and lung vascular leakage (Garcia et
al., 2013; Roversi et al., 2013).
Akari is actively pursuing several clinical
study opportunities in patients with COVID-19 pneumonia in the UK
and U.S. The Company intends to provide additional detail when
these programs are finalized and approved.
“BP, a severe blistering skin condition with no approved
treatments, is an exciting therapeutic target for our drug
candidate, nomacopan,” said Clive Richardson, Chief Executive
Officer of Akari Therapeutics. “Orphan Designation is an important
step in the development of this program and as a gateway into other
dermatological conditions. We believe the dual C5 and LTB4
inhibition has relevance across a wide range of other inflammatory
diseases, including COVID-19.”
The positive opinion issued by the EMA will be sent to the
European Commission which is expected to grant the orphan
designation within 30 days. Orphan designation in the EU allows
Akari to benefit from a number of key incentives, including reduced
regulatory fees, protocol assistance, and market exclusivity, to
develop a medicine for the treatment of a rare disease affecting
not more than five in 10,000 people in the European Union.
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 regarding, among
other things, statements related to the offering, the expected
gross proceeds and the expected closing of the offering. 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; our ability to enter into collaborative,
licensing, and other commercial relationships and on terms
commercially reasonable to us; 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 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.
For more information
Investor Contact:
Peter VozzoWestwicke(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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