Full Press Release Details
Akari Therapeutics Announces Further Clinical Progress
NEW YORK and LONDON, October 11, 2017 - 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the initial five patients enrolled in the COBALT trial, with a suspected co-morbidity unrelated to the treatment, was withdrawn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 na ve PNH patients.
About Akari Therapeutics
Akari 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
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. 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
Mary-Jane Elliott / Sukaina Virji
Consilium Strategic Communications