Full Press Release Details
Akari Therapeutics Receives Positive EMA Opinion on Orphan Designation
for Nomacopan for Bullous Pemphigoid
NEW YORK and LONDON, May 21, 2020 -
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
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
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
Sukaina Virji / Lizzie Seeley
Consilium Strategic Communications