Akari Therapeutics Announces Regulatory Progress Following FDA Meeting
September 21 2017 - 7:00AM
Akari Therapeutics (NASDAQ:AKTX), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics to treat orphan autoimmune and inflammatory diseases,
announces that, following advice from a recent FDA Type B End of
Phase II Meeting, it plans to advance its lead investigational
drug, Coversin™, towards Phase III clinical studies in Paroxysmal
Nocturnal Hemoglobinuria (PNH) in Q1 2018.
“Following our recent FDA meeting, we are working to initiate a
Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr.
David Horn Solomon, Chief Executive Officer of Akari Therapeutics.
“We will continue to work closely with the FDA, benefitting from
our Fast Track status in the U.S., and with the EMA towards
submission of a BLA and MAA, respectively, for Coversin in
PNH.”
Akari plans to carry out two Phase III clinical studies:
CAPSTONE, in naïve PNH patients where eculizumab (Soliris®;
Alexion) is not the standard of care, with co-primary clinical
endpoints based on hemoglobin and transfusion data, and ASSET, a
Phase III clinical study switching PNH patients from eculizumab,
the current standard of care treatment in PNH in the U.S., to
treatment with Coversin.
The FDA indicated that providing safety and efficacy data from
the Company’s clinical trials for the proposed number of unique PNH
patients on Coversin for more than one year seems reasonable,
subject to review of the actual data upon submission. The number
proposed includes patients having C5 polymorphisms conferring
eculizumab resistance.
“Akari continues to build momentum in its complement focused
therapy by advancing Coversin towards Phase III in PNH and Phase II
in aHUS. With Coversin delivered subcutaneously, patients may have
greater independence due to self-administration. Phase II studies
are also planned for a number of other indications where Coversin’s
actions on both the complement and leukotriene (LTB4) pathways play
a role. Its two leading targets in this area are atopic
keratoconjunctivitis (AKC), a rare eye disorder and severe bullous
pemphigoid (BP), a rare skin disorder,” added Solomon.
About Akari TherapeuticsAkari is a
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics to treat orphan
autoimmune and inflammatory diseases, in particular those where the
complement system or leukotrienes or both complement and
leukotrienes together play a primary role in disease progression.
Akari’s lead drug candidate Coversin is a C5 complement inhibitor
currently being evaluated in paroxysmal nocturnal hemoglobinuria
(PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to
its C5 inhibitory activity, Coversin independently and specifically
inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate
Coversin in two conditions, the skin and eye diseases bullous
pemphigoid and atopic keratoconjunctivitis, where the dual action
of Coversin on both C5 and LTB4 may be beneficial. Akari is also
developing other tick derived proteins, including long acting
versions.
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. 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, an inability
or delay in obtaining required regulatory approvals for Coversin
and any other product candidates, which may result in unexpected
cost expenditures; risks inherent in drug development in general;
uncertainties in obtaining successful clinical results for Coversin
and any other product candidates and unexpected costs that may
result therefrom; failure to realize any value of 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 Coversin may not be as large as expected; 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; our inability to obtain additional
capital on acceptable terms, or at all; unexpected cost increases
and pricing pressures; uncertainties of cash flows and inability to
meet working capital needs; and risks and other risk factors
detailed in our public filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 20-F filed
on March 31, 2017. 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:
The Trout Group Tricia Truehart ttruehart@troutgroup.com +1
646 378 2953
Media Contact:
Mary-Jane Elliott / Sukaina Virji Consilium Strategic
Communications +44 (0)20 3709 5700 Akari@consilium-comms.com
Akari Therapeutics (NASDAQ:AKTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Akari Therapeutics (NASDAQ:AKTX)
Historical Stock Chart
From Sep 2023 to Sep 2024