-Phase Ib cohorts demonstrate dose effect and
additional support for once daily dosing--PAS-Coversin pre-clinical
data supports once weekly dosing--Phase II PNH patients identified
with data expected 1Q17--Eculizumab resistant PNH patient treated
for over 9 months with Coversin--New pipeline of tick derived and
engineered proteins--Coversin engineered protein targeting
neuromuscular junction for myasthenia gravis--Proteins targeting
two additional pathways as well as second complement inhibitor-
Akari Therapeutics (NASDAQ:AKTX), an emerging growth,
clinical-stage biopharmaceutical company, announced several
corporate updates that were discussed during an Analyst &
Investor Symposium held during the 58th American Society of
Hematology meeting. The corporate presentation is available
at http://akaritx.com/event/ash-analyst-investor-symposium/.
Clinical Update
Phase IbData from additional cohorts (15mg and
22.5mg daily maintenance cohorts) of the ongoing Phase Ib trial of
Coversin in healthy volunteers showed a dose effect and
demonstrated that the 22.5 mg maintenance dose also supports once
daily dosing, as does the 30 mg maintenance dose as reported
previously.
A chart accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/478326f4-f1a3-4953-b218-911d314180ea
In this double-blind, randomized Phase Ib trial, each cohort of
six normal healthy volunteers is given either a loading dose of
subcutaneous placebo twice a day for two days followed by five days
of a single daily placebo dose (n=2) or a loading dose of 30 mg of
subcutaneous Coversin twice a day for two days followed by five
days of a single daily subcutaneous maintenance dose (n=4).
Data from the 22.5 mg once daily maintenance cohort demonstrated
that subcutaneous Coversin achieved complete complement inhibition
(Elisa CH50 < 8 Eq/ml, lower limit of quantification) within the
first day, and demonstrated complete complement inhibition at the
end of dosing on day seven whether measured using the ELISA or
lytic CH50 assays.
A chart accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/60427ead-3b0e-4906-a834-6679229be85d
The data from the 15 mg once daily maintenance cohort
demonstrated that subcutaneous Coversin achieved complete
complement inhibition (Elisa CH50 < 8 Eq/ml, lower limit of
quantification) within the first day but by day three was unable to
maintain complete complement inhibition at the 24-hour trough
measurement. There have been no injection site reactions reported
in the trial.
“These data support once daily dosing with Coversin,” said Miles
Nunn, PhD, Chief Scientific Officer at Akari. “Demonstration of a
dose effect and concordance between the ELISA CH50 and Lytic Ch50
assays was in-line with expectation.”
PAS-CoversinPASylation® entails modifying
Coversin, a recombinant small protein (17kDa), by adding a 600
amino acid proline/alanine/ serine (PAS) N-terminal fusion tag to
generate PAS-Coversin (68kDa). The unstructured and uncharged
PAS polypeptide increases the apparent molecular size to
approximately 720kDa, slowing kidney clearance and extending the
half-life.
Data from mouse and rat studies of PAS-Coversin demonstrated
that the expected terminal half-life in humans should be
approximately 4 days. Based on these data, Pk modeling supports
that a once weekly dosing regimen is feasible. Akari expects first
in man trials to begin in the fourth quarter of 2017.
Eculizimab-resistant PNH PatientAs reported
previously, an eculizumab-resistant PNH patient had been under
treatment with subcutaneous Coversin for nine months under an
approved clinical protocol. The patient continues to
self-administer Coversin and continues to demonstrate complete
complement inhibition without any change in dose or injection site
reactions. The patient’s most recent reported LDH was below
300. Further, there have been no signs of neutralizing
antibodies.
Phase IIIn the ongoing PNH Phase II trial,
investigators have identified all trial patients. Akari expects to
release data on these patients in the first quarter of 2017.
New Pipeline of Tick Derived and Engineered
Proteins
Platform of Tick Derived and Engineered
ProteinsAkari introduced its discovery program of tick
derived anti-inflammatory proteins. The pipeline includes a wide
range of new and engineered proteins including a second and
potentially orally available C5 inhibitor, compounds binding LTB4,
histamine, serotonin and other parts of the inflammatory pathway,
and tissue targeting compounds including a Coversin specific to the
neuromuscular junction (NMJ) for conditions like myasthenia gravis.
This tissue targeted form of Coversin has the potential to
specifically inhibit complement only at the NMJ and not
systemically and is targeted for first in human trials in the first
half of 2018. Additional details on the new anti-inflammatory
molecules will be provided as early as 1Q17.
“We remain focused on completing our Phase PNH II study and
preparing for our Phase III studies targeted for the summer of
2017,” said Dr. Gur Roshwalb, CEO of Akari. "With the rich
potential pipeline of therapies available from our platform, both
exploiting the power of nature and the ability to take the platform
further by modifying these proteins, we also look forward to
advancing new compounds into the clinic and bringing innovative
therapies for orphan and unmet diseases.”
About Akari Therapeutics PlcAkari is a
clinical-stage biopharmaceutical company focused on the development
and commercialization of life-transforming treatments for a range
of rare and orphan autoimmune and inflammatory diseases caused by
dysregulation of complement C5 and Leukotriene B4 (LTB4), including
paroxysmal nocturnal hemoglobinuria (“PNH”), atypical Hemolytic
Uremic Syndrome (“aHUS”), and Guillain Barré syndrome
(“GBS”). Akari’s lead product candidate, Coversin™ complement
inhibitor, a second-generation complement inhibitor, acts on
complement component-C5, preventing the release of C5a and the
formation of C5b–9 (also known as the membrane attack complex or
MAC), and independently also inhibits LTB4 activity. C5
inhibition is growing in importance in a range of rare autoimmune
diseases related to dysregulation of the complement component of
the immune system, including PNH, aHUS, and GBS. Exploiting the
power of nature, Akari is also developing other tick derived
proteins, both native and engineered and expects to bring
additional compounds to clinical trials over the next several
years.
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: an
inability or delay in obtaining required regulatory approvals for
CoversinTM 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
CoversinTM and any other product candidates and unexpected costs
that may result therefrom; failure to realize any value of
CoversinTM 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 CoversinTM 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 10-K filed
on March 23, 2016. 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.
Contact:
Investor Contact:
The Trout Group
Lee Stern
lstern@troutgroup.com
646-378-2922
Media Contact:
Susan Forman / Laura Radocaj
Dian Griesel Int'l.
(212) 825-3210
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