Akari Therapeutics Announces New Data Supporting Use of Drug Candidate Votucalis Targeting Difficult to Treat Pain and Itch
March 09 2022 - 7:30AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage
biopharmaceutical company focused on innovative therapeutics to
treat orphan autoimmune and inflammatory diseases, today announced
new preclinical data published in Frontiers in Pharmacology
demonstrating that Akari’s pipeline candidate votucalis has
potential as a treatment for pain and itch associated with
conditions such as atopic dermatitis, psoriasis and neuropathic
pain.
Votucalis is a broad-acting histamine inhibitor that was
discovered through the same research program that yielded Akari’s
lead drug, nomacopan, a complement and leukotriene inhibitor
currently in Phase III clinical development. Votucalis, by binding
to histamine, inhibits all four histamine G-protein coupled
receptors (GPCRs): H1, H2, H3 and H4 opening up new treatment
options currently not available with marketed antihistamine
treatments that target only the H1 or H2 receptors. Activation of
these receptors can induce multiple pathophysiological processes,
including chronic pain, itch and inflammation.
Clive Richardson, CEO of Akari Therapeutics,
said: “The unique inhibition of the histamine pathway by
votucalis affords Akari the potential to expand our existing
dermatology franchise as well as exploring votucalis as a treatment
for pain where current treatments such as opioids can be
ineffective and can have serious side-effects including addiction.
We look forward to continuing our collaboration with Durham and
Newcastle Universities to move this program forward.”
The data published today were from two preclinical models of
itch and pain in mice.
In pain, votucalis produced a potent and
complete anti-sensation effect in a mechanical
hypersensitivity model. Local administration of votucalis was
achieved at significantly lower doses and produced a longer
duration of effect than systemic administration. The research also
showed that Votucalis does not enter the brain, which means it is
unlikely to cause central nervous system (CNS) mediated side
effects typical of opioids.
In itch, votucalis provided inhibition of histaminergic itch of
around 62%, with the potential for greater reduction with higher
dosing. Peripheral H1 and H2 or central H4 antagonism inhibited
histaminergic itch of around 64%, 53% and 27 %, respectively. When
peripheral antagonists were combined with votucalis, itch was
reduced between 80% and 90%. As in pain, the local route of
administration was most effective, opening up the potential for
topical administration. Prior work in human skin cadaver
experiments indicate that votucalis may be suitable for topical
delivery.
A further program of work is ongoing with our collaborators Dr.
Paul Chazot, Durham University, and Dr Ilona Obara, Newcastle
University, focused on the effect of locally administered nomacopan
on inflammation and pain. This should allow Akari to begin planning
for a clinical program by the end of the year benefiting from an
already advanced GMP manufacturing program.
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, nomacopan, is a
C5 complement inhibitor that also independently and specifically
inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently
being clinically evaluated in four areas: bullous pemphigoid (BP),
thrombotic microangiopathy (TMA), as well as programs in the eye
and lung.
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 Nomacopan 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 Nomacopan and any other product
candidates and unexpected costs that may result therefrom;
difficulties enrolling patients in our clinical trials; our ability
to enter into collaborative, licensing, and other commercial
relationships and on terms commercially reasonable to us; failure
to realize any value of Nomacopan 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 U.S. Food and Drug
Administration (FDA) and European Medicines Agency (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 Nomacopan may not
be as large as expected; risks associated with the impact of the
COVID-19 pandemic; 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 Securities and Exchange
Commission (SEC), including our most recently filed Annual Report
on Form 20-F filed with the SEC. 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
ICR Westwicke
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji/ Maya Bennison
Consilium Strategic Communications
Akari@consilium-comms.com
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