Akari Therapeutics Announces New Data Highlighting Differentiation of Drug Candidate Coversin
November 30 2018 - 4:05PM
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company
focused on innovative therapeutics to treat orphan autoimmune and
inflammatory diseases where the complement and/or leukotriene
systems are implicated, today announced recent developments and
supporting data which underscore the differentiation of Coversin.
“We are encouraged by new data that demonstrates the potential
for improved patient comfort and ease of use. Alongside this focus
on patient convenience we continue to develop Coversin as a
differentiated treatment by means of its combined complement C5 and
LTB4 inhibitory activity with early data readouts of our bullous
pemphigoid (BP) and atopic keratoconjunctivitis (AKC) trials
expected in first quarter 2019,” said Clive Richardson, Interim
Chief Executive Officer of Akari Therapeutics.
New data highlights
- New data showing Coversin can be concentrated to 150mg/ml at
low viscosity validates the enhanced convenience of the
auto-injector pen across Akari subcutaneous program – currently
PNH, thrombotic microangiopathy (TMA) and BP.
- New highly concentrated formulation with small (0.3mL) volume
and water-like viscosity allows ease of administration and
increasing patient comfort.
- Single cartridge to contain seven days of dosing which is
stable at room temperature allowing patients to carry drug with
them.
- A second eculizumab-resistant patient with PNH has now received
more than six months of Coversin therapy treatment.
- Resistant to eculizumab because of a known C5 polymorphism
(p.Arg885Cys).
- Previously transfusion-dependent and has now been transfusion
independent for five months.
- New pharmacokinetic data for PAS Coversin supports once weekly
dosing.
- Preclinical data investigating the half-life of PAS Coversin in
three species supports potential for once weekly dosing in
man.
Clinical program update
- Coversin clinical trials focused on orphan diseases mediated by
both the complement and leukotriene pathways with initial data
readouts in the first quarter 2019:
- Phase II trial in patients with BP, a severe blistering skin
disease.
- Phase I/II trial in patients with AKC, a sight-threatening
surface of the eye condition.
- Coversin clinical trials in orphan diseases in which complement
dysregulation is the primary disease driver:
- Two trials open in PNH: a Phase III trial in naïve patients and
a Phase II trial in patients who are resistant to eculizumab.
- An open Phase II trial in atypical hemolytic syndrome (aHUS), a
severe thrombotic microangiopathy.
- Pediatric patients with thrombotic microangiopathy (TMA) post
bone marrow transplant being treated with Coversin on named patient
basis.
- Long-term safety study for Coversin
- Total cumulative number of patient years on Coversin treatment
approximately 15 patient years.
- As of the end of October 2018 all patients in the long-term
study had been treated for more than 15 months and the first
patient for 34 months. The second resistant patient has just
entered the long term study.
- No drug related serious adverse events and no neutralizing
antibodies reported to date and continued full inhibition of
terminal complement activity.
- Six PNH patients were transfusion dependent prior to treatment
with Coversin, of which four (67%) in the long-term study are now
transfusion independent; two remain on transfusion.
About Akari Therapeutics Akari is a
biopharmaceutical company focused on developing inhibitors of acute
and chronic inflammation, specifically for the treatment of rare
and orphan diseases, in particular those where the complement (C5)
or leukotriene (LTB4) systems, or both complement and leukotrienes
together, play a primary role in disease progression. Akari's lead
drug candidate, Coversin, is a C5 complement inhibitor that also
independently and specifically inhibits leukotriene B4 (LTB4)
activity. Coversin is currently being clinically evaluated in four
indications: bullous pemphigoid (BP), atopic keratoconjunctivitis
(AKC), atypical hemolytic uremic syndrome (aHUS), and paroxysmal
nocturnal hemoglobinuria (PNH). Akari believes that the dual action
of Coversin on both C5 and LTB4 may be beneficial in AKC, BP, and
aHUS. Akari is also developing other tick derived proteins,
including longer acting versions.
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, our ability to continue as a going concern;
uncertainties of cash flows and inability to meet working capital
needs; an inability or delay in obtaining required regulatory
approvals for Coversin and any other product candidates, which may
result in unexpected cost expenditures; our ability to obtain
orphan drug designation in additional indications; 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;
difficulties enrolling patients in our clinical trials; 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 departure of
our former Chief Executive Officers and other executive officers;
risks related to material weaknesses in our internal controls over
financial reporting and risks relating to the ineffectiveness of
our disclosure controls and procedures; risks associated with the
putative shareholder class action and SEC investigation;
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; unexpected cost increases and
pricing pressures and risks and other risk factors detailed in our
public filings with the U.S. Securities and Exchange
Commission, including our most recently filed Annual Report on Form
20-F filed with the SEC on July 18, 2018. 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 Vozzo Westwicke Partners (443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji / Nicholas
Brown Consilium Strategic Communications +44 (0)20 3709 5700
Akari@consilium-comms.com
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