Akari Therapeutics Announces Successful Scientific Advice Meeting with the European Medicines Agency (EMA) Establishing a Cle...
October 01 2020 - 8:00AM
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, announces completion of a scientific advice
meeting with the European Medicines Agency (EMA) in advance of
initiating a Phase III pivotal study of nomacopan for the treatment
of bullous pemphigoid (BP). Following prior similar agreement from
the U.S. Food and Drug Administration (FDA) at an End of Phase II
meeting, the EMA has agreed to Akari’s proposal for a Phase III
randomized placebo-controlled study with nomacopan in patients with
moderate to severe BP with a primary endpoint of disease remission
on minimal oral corticosteroids (OCS). Akari believes the
overlapping advice now received from both agencies allows the
pivotal Phase III study design to satisfy both the FDA and EMA
recommendations.
BP is a severe orphan autoimmune inflammatory blistering skin
disease with no approved treatments in the U.S. and Europe with an
approximately three-fold increase in mortality in the BP population
treated with current standard of care. The prevalence of BP is
estimated to be over 100,000 patients in the U.S. and Europe.
In the Phase III study, patients will be randomized to receive
either nomacopan plus oral corticosteroids (OCS) or placebo plus
OCS for six months. Following an initial stabilization phase, the
steroids will be tapered according to disease response to a minimal
level of OCS (< 0.1mg/kg/d prednisone or equivalent) which is
considered safe. If disease response is rapid, as was seen in the
nomacopan Phase II study in BP patients, OCS could be tapered to
the minimal level within six weeks. Once patients are on minimal
OCS plus either nomacopan or placebo, the primary endpoint will be
achieved by those patients with complete disease remission on
minimal OCS for eight weeks or longer during the 24-week treatment
period. Patients will then enter an extension study to provide at
least six months of additional data. An important secondary
endpoint is reduction in cumulative OCS use on nomacopan as high
dose OCS are regarded as unsafe in this vulnerable patient
population.
Clive Richardson, Chief Executive Officer of Akari Therapeutics,
said, “Following our successful FDA End of Phase II meeting, we are
very pleased that the EMA has also agreed that we can proceed with
our proposed pivotal Phase III study. The advice received from both
agencies provides a clear pathway to a potential approval in Europe
and the U.S. for nomacopan in patients with BP. We plan to initiate
the study in both the U.S. and Europe during the first half of
2021.”
Background on Bullous Pemphigoid (BP)
In BP patients there is evidence that both terminal complement
activation (via complement component C5) and the lipid mediator
leukotriene B4 (LTB4) have a central role in driving the disease.
Ex vivo data in BP patients, published in the August 2019 edition
of JCI Insight, showed a pronounced accumulation of LTB4 and C5 and
its activation products in the inflamed skin of BP patients. This
underlies the rationale for treatment with nomacopan which is a
unique bifunctional inhibitor of both C5 and LTB4 and a range of
downstream cytokines. In addition to BP, the Company believes this
unique mode of action underpins the activity of nomacopan across
the Company’s other target conditions – TMA-HSCT, COVID pneumonia
and ophthalmology as well as other emerging clinical
indications.
About Akari TherapeuticsAkari 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 (formerly known as Coversin), is a C5
complement inhibitor that also independently and specifically
inhibits leukotriene B4 (LTB4) activity.
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. You should not
place undue reliance upon the Company’s forward looking statements.
Except as required by law, the Company undertakes no obligation to
revise or update any forward-looking statements in order to reflect
any event or circumstance that may arise after the date of this
press release. 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 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 nomacopan may not be as large as
expected; risks associated with the impact of the outbreak of
coronavirus; risks associated with the 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. 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.
Investor Contact:
Peter VozzoWestwicke+1 (443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Lizzie SeeleyConsilium Strategic
Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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