Akari Therapeutics Announces Publication of Phase II Data of Investigational Nomacopan for the Treatment of Bullous Pemphigoid (BP) in JAMA Dermatology
May 10 2022 - 7:00AM
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) Dermatology.
https://jamanetwork.com/journals/jamadermatology/article-abstract/2791461
“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
A 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.
References:
- IPPF – International
Pemphigus & Pemphigoid Foundation – Pemphigoid page.
https://www.pemphigus.org/pemphigoid/. Accessed May 6, 2022
- Tedbirt B, Gillibert
A, Andrieu E, Hébert V, Bastos S, Korman NJ, Tang MBY, Li J,
Borradori L, Cortés B, Kim SC, Gual A, Xiao T, Wieland CN, Fairley
JA, Ezzedine K, Joly P. Mixed Individual-Aggregate Data on
All-Cause Mortality in Bullous Pemphigoid: A Meta-analysis. JAMA
Dermatol. 2021 Apr 1;157(4):421-430. doi:
10.1001/jamadermatol.2020.5598. PMID: 33729430; PMCID:
PMC7970384.
- Murrell DF, Daniel BS, Joly P, et al. Definitions and outcome
measures for bullous pemphigoid: recommendations by an
international panel of experts. J Am Acad Dermatol.
2012;66(3):479-485. doi:10.1016/j.jaad.2011.06.032
- Wijayanti A, Zhao CY, Boettiger D, Chiang YZ, Ishii N,
Hashimoto T, Murrell DF. The Reliability, Validity and
Responsiveness of Two Disease Scores (BPDAI and ABSIS) for Bullous
Pemphigoid: Which One to Use? Acta Derm Venereol. 2017 Jan
4;97(1):24-31. doi: 10.2340/00015555-2473. PMID: 27244117.
About Akari TherapeuticsAkari 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
StatementsCertain 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 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 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
Investor Contact:Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji/ Maya BennisonConsilium Strategic
CommunicationsAkari@consilium-comms.com
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