Full Press Release Details
Akari Therapeutics Announces Initiation of Pivotal Phase III Trial
of Nomacopan in Bullous Pemphigoid (BP)
NEW YORK and LONDON, April 12, 2021 - Akari Therapeutics, Plc
(Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where
the complement and leukotriene systems are implicated, announces that an IND is now open with the U.S. Food and Drug Administration (FDA)
for its multicenter Phase III study with nomacopan for the treatment of moderate and severe BP, allowing clinical sites to open mid-2021,
subject to the ongoing impact of COVID related restrictions. Akari has been granted orphan drug designation for nomacopan for the treatment
of BP by both the FDA and the European Medicines Agency (EMA).
"With the BP IND now open we look forward to starting the pivotal
Phase III study of nomacopan in patients with this severe dermatological condition, for which there is no specific approved treatment
in the U.S. or Europe," commented Clive Richardson, Chief Executive Officer of Akari Therapeutics. "Success in BP could also
open up a range of other severe dermatological conditions for treatment with nomacopan where C5 and LTB4 are implicated including hidradenitis
suppurativa, epidermolysis bullosa acquisita and mucous membrane pemphigoid."
BP may last several years in the absence of treatment, has a tendency
to relapse and is most common in the elderly. It is primarily treated with potent oral steroids for six months or more which bring with
them deleterious side effects and a three-fold or larger increase in mortality. The prevalence of BP is estimated to be approximately
120,000 patients in U.S. and EU with moderate and severe patients making up around three quarters of the patient population.
In patients with BP there is evidence that nomacopan's ability
to inhibit C5 and LTB4 gives it a unique potential therapeutic advantage which is upstream of other approaches (such as cytokine inhibitors)
that are being investigated for treatment of BP. In the Phase II nomacopan study, patients with BP had elevated levels of LTB4 in their
serum and in addition both C5 and LTB4 levels are elevated in blister fluid from BP patients, illustrating the local activation of both
these inflammatory pathways. Moreover, in a pre-clinical model (Sezin et al 2019) the absolute body surface area affected by blisters
was reduced by approximately 50% by inhibiting LTB4 alone but by approximately 80% by inhibiting both LTB4 and C5.
Akari's pivotal Phase III trial design, which is a randomized
placebo-controlled study with nomacopan in patients with moderate to severe BP with a primary endpoint of disease remission on minimal
oral corticosteroids was based on the Company's successful end-of-Phase II meetings held last year with both the FDA and the EMA.
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.
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; 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 information
Sukaina Virji/ / Ashley Tapp
Consilium Strategic Communications