Full Press Release Details
Akari Therapeutics Announces Completion
of Phase II COBALT Trial of Coversin in Patients with PNH and Further Progress of Clinical Trials
NEW YORK and LONDON, February 6, 2018 -
Akari Therapeutics, Plc (NASDAQ:AKTX) ("Akari" or "the Company"), a biopharmaceutical company focused on
the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announces
additional data for its Phase II COBALT clinical trial and provides an update on other clinical trials with Coversin.
The final three patients enrolled in the
eight patient 90-day open-label Phase II single-arm COBALT clinical trial for patients with PNH who have never received a complement
blocking therapy, have now completed the trial. They had a median LDH (lactate dehydrogenase; an indicator of hemolysis) of <1.5
times the ULN (upper limit of normal) at day 28, day 60 and day 90. As previously disclosed, these three patients utilized the
higher 45mg per day subcutaneous dose of Coversin. The 45mg dosing regimen is the intended dose for the Phase III PNH trials of
Coversin discussed with the U.S. Food and Drug Administration (FDA) in September 2017.
The trial achieved its primary endpoint,
defined as a reduction in LDH to 1.8 times the ULN at day 28. Seven of the eight enrolled patients completed the 90-day
Of the seven patients who completed the
COBALT trial, six were transfusion-dependent prior to the trial. Of those six patients, three have not required transfusions while
on Coversin during the COBALT trial. All seven patients that completed the study had a CH50 level below the limit of quantification
(<8 CH50 U Eq/mL) after the ablating dose phase indicating total blockade of the terminal complement pathway.
All of the seven patients who completed
the COBALT trial have entered the long-term safety study, CONSERVE, and have been receiving Coversin subcutaneously for between
4 to 13 months. The CONSERVE safety database is intended to contribute to the approval package after completion of Phase III trials
and the primary objective of CONSERVE is to determine the safety profile of long-term Coversin treatment. To date there have been
no drug-related serious adverse events reported.
The three long term (more than six months
in CONSERVE) patients in CONSERVE, who were transfusion dependent on entry into COBALT, have remained transfusion dependent throughout
COBALT and CONSERVE and have seen relatively stable LDH levels with mean values between 1.8 and 2.2 times the ULN. One additional
long term patient has experienced intermittent rises in LDH, while one of the patients recently enrolled in CONSERVE experienced
a rise in LDH believed to be associated with a febrile illness - their LDH levels have ranged between 1.8 to 3.1 times the
ULN. The last two patients to complete COBALT have just entered CONSERVE with LDH levels of 1.5 and 1.2 times the ULN. 2
A Phase III trial of Coversin in PNH patients
who have not previously been treated with a complement inhibitor (CAPSTONE) is anticipated to begin at the end of the first quarter
The Company also announces the following
"We are pleased to announce the completion
of our Phase II program in PNH, with the last three patients achieving a low LDH level at day 28 on patient-administered 45mg per
day - the dose we intend to use in our upcoming Phase III CAPSTONE trial," commented Dr. David Horn Solomon, Chief
Executive Officer of Akari Therapeutics. "We anticipate progressing into a Phase III clinical trial in PNH by the end of
the first quarter of 2018 and remain focused on advancing Coversin into Phase II trials this year in AKC and BP, both orphan indications
with significant unmet need. This is an exciting time for Akari, patients, and caregivers as we continue to build on the momentum
in the business and work towards commercializing treatments for orphan autoimmune and inflammatory diseases."
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
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.
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; risks associated with the putative shareholder class action and SEC requests for information;
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 and in our Report on Form 6-K filed with the SEC on October 17, 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 / Nicholas
Consilium Strategic Communications