Akari Therapeutics’ Nomacopan Granted U.S. Orphan Drug Designation for Bullous Pemphigoid
September 13 2019 - 8:00AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company
focused on innovative therapeutics to treat orphan autoimmune and
inflammatory diseases where the complement (C5) and/or leukotriene
(LTB4) systems are implicated, today announced that the U.S. Food
and Drug Administration (FDA) has granted orphan drug designation
for nomacopan for the treatment of bullous pemphigoid (BP).
“BP, a severe blistering skin condition with no approved
treatments, is an exciting therapeutic target for our lead drug
candidate, nomacopan. It is also a disease of increasing prevalence
due to an aging population and improving diagnosis,” said Clive
Richardson, Chief Executive Officer of Akari Therapeutics. “Orphan
drug designation for nomacopan is a major step forward for the
program, positioning nomacopan for eligibility for an additional
seven years of marketing exclusivity in BP if nomacopan is approved
by the FDA. This news is in addition to the recent orphan drug
designation received for our HSCT-TMA program.”
The Company plans to release new safety and efficacy data from
an ongoing Phase II trial with nomacopan in patients with BP at an
oral presentation by Dr. Christian Sadik at the 28th European
Academy of Dermatology and Venereology (EADV) Congress on October
10, 2019. In August, the Company announced new data demonstrating
the synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory
activity in pemphigoid disease, generated by Dr. Christian Sadik’s
group at University of Lubeck, Germany, and published in the August
2019 edition of JCI Insight [link].
Orphan drug designation by the FDA is granted to promote the
development of drugs that target conditions affecting 200,000 or
fewer U.S. patients annually and that are expected to provide
significant therapeutic advantage over existing treatments. Orphan
designation qualifies Akari for various benefits, including seven
years of market exclusivity following marketing approval, tax
credits on U.S. clinical trials, eligibility for orphan drug
grants, and a waiver of certain administrative fees.
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
(formerly known as Coversin), is a C5 complement inhibitor that
also independently and specifically inhibits leukotriene B4 (LTB4)
activity. Nomacopan is currently being clinically evaluated in four
indications: bullous pemphigoid (BP), atopic keratoconjunctivitis
(AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal
hemoglobinuria (PNH). Akari believes that the dual action of
nomacopan on both C5 and LTB4 may be beneficial in both AKC and
BP.
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 regarding, among other
things, statements related to the offering, the expected gross
proceeds and the expected closing of the offering. 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; 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 departure of our former Chief Executive
Officers and other executive officers; 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.
For more informationInvestor Contact:
Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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