Full Press Release Details
Akari Therapeutics Announces Publication
of Phase II Data of Investigational Nomacopan for the Treatment of Bullous Pemphigoid (BP) in JAMA Dermatology
YORK and LONDON, May 10, 2022 (GLOBE NEWSWIRE) - Akari Therapeutics, plc (Nasdaq: AKTX), a late-stage biotechnology company
focused on development of advanced therapies for autoimmune and inflammatory diseases, announced positive results from the Phase II study
of investigational nomacopan in bullous pemphigoid (BP) were published online in the Journal of the American Medical Association (JAMA)
"These positive Phase II data advanced our understanding of
the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III clinical trial, which is open for enrollment
now," said Rachelle Jacques, President and CEO of Akari Therapeutics.
BP is the most common autoimmune blistering skin disease. It typically
affects people over the age of 65.1 There are no approved therapies but superpotent topical steroids and high dose oral corticosteroids
(OCS) are the current standard of care. The mortality rate in BP is ~three-fold higher than the general population due to the disease
itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high
dose OCS.2 There is significant unmet need for an effective steroid-sparing therapy.
The goal of the Phase II study was to examine the safety and therapeutic
potential of bispecific recombinant nomacopan, an inhibitor of both leukotriene B4 (LTB4) and complement C5, in patients with BP. The
Phase II trial was a multicenter, single-group, nonrandomized controlled study conducted in the dermatology departments of hospitals
in the Netherlands and Germany. Participants were enrolled between September 2018 and April 2020. Adult patients (aged >18
years) with mild to moderate, new-onset or relapsing BP were recruited into the study. Patients received nomacopan, 90 mg, subcutaneously
on day one and 30 mg subcutaneously once daily until day 42.
The primary end point was the proportion of patients with Common Terminology
Criteria for Adverse Events (CTCAE) grade three (severe AE), grade four (life-threatening or disabling AE), and grade five (death related
to AE) adverse events associated, or possibly associated with nomacopan. Secondary end points included mean absolute and percentage changes
in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score, the BPDAI pruritus score, and the patient-reported outcome measures
Dermatology Life Quality Index (DLQI) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL). The BPDAI activity score
provides an objective measure of disease extent by assessing blisters and urticarial/erythematous lesions affecting particular regions
of the body surface and mucous membranes.3
total of nine BP patients with a median age of 75 and a range of 55-85 years were included in the trial. There were no serious adverse
events or CTCAE grade 3, 4 or 5 associated or possibly associated with nomacopan during the trial. The mean (90% CI) BPDAI activity score
decreased from 32.0 (8.7) points on day one to 19.6 (9.0) points on day 42. Seven of nine patients (77.8%) responded to nomacopan with
a reduction in the BPDAI activity score of at least eight points between day one and 42; where the minimum clinically important difference
(MCID) in BPDAI activity is four.4 In three responders, the reduction in BPDAI was 80% or greater. On day 42, the mean (90%
CI) BPDAI pruritus score had decreased by 6.8 (4.6) points from 17.6 (4.0) points on day one. The mean (90% CI) DLQI score decreased
from 11.3 (4.2) points at baseline to 6.4 (3.8) points by day 42, and the mean (90% CI) TABQOL score decreased from 14.6 (5.4) points
at baseline to 10.3 (5.0) points on day 42.
About Akari Therapeutics
Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company focused on developing advanced therapies for autoimmune and inflammatory
diseases. Akari's lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of C5 complement activation and leukotriene
B4 (LTB4) activity. The Akari pipeline includes two late-stage programs for bullous pemphigoid (BP) and thrombotic microangiopathy (TMA),
as well as earlier stage research and development programs in eye and lung diseases with significant unmet need. For more information
about Akari, please visit akaritx.com.
Cautionary Note Regarding Forward-Looking
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 there; 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; 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/ Maya Bennison
Consilium Strategic Communications