Akari Therapeutics Announces Further Clinical Progress
October 11 2017 - 7:00AM
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company
focused on developing inhibitors of acute and chronic inflammation,
specifically the complement system, the eicosanoid system and the
bioamine system for the treatment of rare and orphan diseases,
announces that three additional patients have been enrolled in the
ongoing Phase II COBALT clinical trial of Coversin™ in patients
with paroxysmal nocturnal hemoglobinuria (PNH).
COBALT, the Phase II 90-day, open label single arm clinical
trial, has enrolled a total of eight patients, four of whom have
completed the trial and were reported on at the European Hematology
Association conference in June 2017. These four patients have
all moved into Akari’s long-term safety study, CONSERVE. One
of the initial five patients enrolled in the COBALT trial, with a
suspected co-morbidity unrelated to the treatment, was withdrawn
from the study on day 43.
Three new patients were enrolled pursuant to an amended protocol
based on a revised dosing regimen which included changing the
maintenance phase from a single dose of 30mg every 24 hours to a
single dose of 45mg every 24 hours. The three newly enrolled
patients on the revised dosing regimen have now completed
approximately 8, 3 and 2 weeks, respectively. The primary endpoint
in this clinical trial is reduction in serum LDH (lactate
dehydrogenase; an indication of hemolysis) to ≤1.8 times the ULN
(upper limit of normal) for the investigator’s reference laboratory
or 500 I U/L, whichever is the lower from day 1 (pre-dose) to day
28. The first of the three patients had a LDH value of 1.5
times the ULN at day 28. The other two patients have not yet
reached the primary endpoint measurement date. To date, there
have been no drug-related serious adverse events. The data
reported is taken from the current electronic case report
forms.
Akari plans to provide an update on all PNH patients currently
enrolled at the American Society of Hematology Annual Meeting to be
held December 9-12, 2017.
Akari plans to advance Coversin towards Phase III clinical
trials beginning with CAPSTONE in Q1 2018, a Phase III clinical
trial of Coversin in naïve PNH patients.
About Akari TherapeuticsAkari is a
biopharmaceutical company focused on developing inhibitors of acute
and chronic inflammation, specifically the complement system, the
eicosanoid system and the bioamine system for the treatment of rare
and orphan 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:
Peter VozzoWestwicke Partners(443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina VirjiConsilium Strategic
Communications+44 (0)20 3709 5700Akari@consilium-comms.com
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