Akari Therapeutics Announces Phase II COBALT trial of Coversin™ in Patients with PNH Met the Primary Endpoint
December 08 2017 - 4:05PM
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics to treat orphan autoimmune and inflammatory diseases,
today announced that the three additional patients that were
enrolled into the Phase II COBALT trial of CoversinTM in paroxysmal
nocturnal hemoglobinuria (PNH), considered together with the
earlier five patients, met the primary endpoint. 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
to day 28. The last three patients enrolled into the Phase II
trial utilized a revised dosing regimen which included changing the
initial dose of 30 mg every 24 hours to a dose of 45 mg every 24
hours. The 45 mg dosing regimen is the intended dose for the
Phase III PNH trials of Coversin discussed with the U.S. Food and
Drug Administration (FDA) at a Type B End of Phase II Meeting in
September 2017.
The median LDH value of the last three patients enrolled, who
utilised the higher 45mg dose, rapidly fell to 1.5 times the ULN at
day 14 and below 1.5 times the ULN at day 28 and day 60, which was
lower than the earlier patients on a 30mg dose who had a median LDH
value of 2.2 times the ULN at day 28 and 1.7 times the ULN at
day 60. In a total of 70 patient-months exposure, there have
been no drug-related serious adverse events. In the eight
patients in the COBALT Phase II 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 and during the Company’s long-term safety
study, CONSERVE.
COBALT, the Phase II 90-day, open label single arm clinical
trial is evaluating Coversin in patients with PNH who have never
received a complement blocking therapy. All patients who have
completed the Phase II COBALT trial entered the long-term safety
study, CONSERVE. One patient in COBALT and one patient in CONSERVE
with rising LDH levels were, as an alternative to higher dosing,
moved as per protocol to twice daily dosing with a subsequent fall
in LDH. The median LDH levels of the other three patients at Day
180 of CONSERVE was 1.77 times the ULN.
Under a separate Eculuzimab-resistent protocol, a ninth patient
has been treated for 22 months with an average LDH level from month
2 onwards of 1.3 times the ULN.
“We are encouraged by the results from the Phase II trial,
especially the lower mean LDH value observed in the last three
patients enrolled into the trial treated with 45 mg daily compared
to the patients treated with 30 mg daily,” commented Dr. David
Solomon, Chief Executive Officer of Akari Therapeutics. “We are on
track to progress into Phase III clinical trials in the first
quarter of 2018 with the revised dosing regimen of 45 mg, as
discussed with the FDA.”
“The 45 mg per day dosing of Coversin, as used for the last
three patients recently enrolled into COBALT, saw plasma LDH levels
in these patients fall rapidly to 1.5 times the ULN or below by Day
28,” said Principal Investigator Anita Hill, M.D.,
PhD, MRCP, FRCPath, Consultant Haematologist for Leeds
Teaching Hospitals NHS Trust, U.K., and Lead Clinician for the
National PNH Service in England. “The Phase II data
suggest that Coversin is a potential alternative to existing
therapy for patients with PNH, and could allow independence from
intravenous infusions through self-administration.”
Akari plans to commence two Phase III PNH clinical trials with
Coversin beginning with CAPSTONE in the first quarter of 2018, a
Phase III trial that will include treatment naïve patients.
The second Phase III trial, ASSET, is planned for the second half
of 2018 and will include Soliris® switch patients.
Akari Therapeutics Investor & Analyst Event
Akari Therapeutics will host a reception on Sunday, December 10,
2017, beginning at 7:30 p.m. ET, with presentations beginning
promptly at 8:00 p.m. ET. Presentations will include a leading
clinical investigator, as well as Company management. The
event will take place at the Omni Atlanta Hotel at CNN Center in
the Maple Room. This event will be webcast live and can be accessed
under “Events” in the Investor Relations section of the Company's
website at www.akaritx.com, as well as archived for future
review.
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; 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
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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