TIDMRLM
RNS Number : 1054P
Realm Therapeutics PLC
24 May 2018
Realm Therapeutics Completes Enrollment in Phase 2 Study of
PR022 for Atopic Dermatitis
Company Further Strengthens IP Portfolio with New USPTO Notice
of Allowance
Reiterates Plans to File an Initial New Drug (IND) Application
for
PR022 in Psoriasis in Q1'19
MALVERN, PA, May 24, 2018 - Realm Therapeutics plc (AIM:RLM), a
clinical stage biopharmaceutical company focused on developing
novel therapeutics in immune-mediated diseases, today announces
that the Company has completed enrollment in its Phase 2 study of
PR022, Realm's first-in-class topical IL-4 / IL-13 inhibitor, for
the treatment of Atopic Dermatitis. The trial is being conducted in
the United States and the Company continues to expect to report top
line results in the third quarter of this year.
"This Phase 2 study is designed to demonstrate that PR022, our
proprietary topical gel formulation of high concentration
hypochlorous acid, has the potential to be a clinically meaningful
treatment alternative for patients suffering from Atopic
Dermatitis," said Alex Martin, Chief Executive Officer of Realm.
"In pre-clinical models of Atopic Dermatitis, PR022 has shown
immunomodulatory effects, without the same immunosuppressive side
effects often associated with steroids, which are the current
standard of care. This data suggests a potential clinical advantage
for PR022 that could be especially beneficial for the large
pediatric segment of the Atopic Dermatitis patient population. We
look forward to sharing the top line results of this study in the
third quarter."
The Phase 2 study is a randomized, double-blind,
vehicle-controlled, multicenter, parallel-group study assessing the
safety and efficacy of multiple doses of PR022 in 122 adult
patients with mild-to-moderate Atopic Dermatitis. Multiple
endpoints are being explored, including Eczema Area and Severity
Index (EASI), an investigator-assessed tool used to measure the
extent (area) and severity of atopic eczema; Investigator Global
Assessment (IGA), an investigator-assessed instrument measuring
severity of Atopic Dermatitis on a 5 grade scale; as well as
additional assessments of pruritus and quality of life.
The Company also announces that the United States Patent and
Trademark Office (USPTO) has issued a notice of allowance for a new
patent that expands Realm's intellectual property portfolio related
to its proprietary immunomodulatory technology. U.S. Patent
Application No. 15/184,207, entitled "Stabilized Hypohalous Acid
Solutions," provides further coverage for composition of matter for
the stabilized formulation of HOCl, for Realm's gel formulations
PR022 and RLM023, as well as methods of treatment with these
formulations. The patent includes specific claims for treating
Atopic Dermatitis, Psoriasis and Acne.
"This additional patent allowance expands Realm's intellectual
property protection for formulations based on our proprietary
platform technology," continued Mr. Martin. "We believe our
technology has broad-spectrum immunomodulatory effects, with
potential applications in Atopic Dermatitis, Acne, Psoriasis and
potentially other immune-mediated diseases. As previously
announced, we plan to file two Initial New Drug (IND) applications
- one for RLM023 in Acne, expected by the end of this year, and
another for PR022 in Psoriasis expected in Q1 2019."
About PR022
PR022 is a proprietary, non-alcohol based, topical gel
formulation of high concentration HOCl, potentially offering a
differentiated mechanism of action for the treatment of Atopic
Dermatitis. In pre--clinical models of Atopic Dermatitis, the
Company has demonstrated that PR022 is associated with down
modulation of key cytokines IL-4, IL-13 and TARC, as well as
cytokines associated with itch, including IL-31 and TSLP.
Importantly, these results were demonstrated without the typical
immunosuppressive impact of steroids, the current standard of care,
suggesting a potential clinical advantage for PR022. Realm is also
evaluating PR022 for Psoriasis. Pre-clinical studies have shown in
vitro and in vivo that HOCl can down modulate key cytokines
TNF-<ALPHA>, IL-6, and IL-12, which have been reported at
elevated levels in patients with Psoriasis.
About RLM023
RLM023 is a topical formulation of high-concentration HOCl that
is being optimized for Acne. Realm believes that a HOCl based
formulation may offer a promising treatment for Acne due to its
anti-inflammatory and anti-microbial properties. In in vitro and in
vivo pre-clinical studies, HOCl demonstrated, a reduction in the
expression of pro-inflammatory cytokines such as TNF-<ALPHA>,
IL-1<BETA>, IL-8 and IL-12, which have been reported to be
key cytokines associated with Acne pathogenesis.
About Atopic Dermatitis
Atopic Dermatitis, a serious form of eczema, is a chronic,
relapsing, inflammatory disease characterized by itchy, inflamed
skin, which poses a significant burden on patients' quality of life
and on the overall health care system. It is most commonly first
diagnosed in childhood. Patients with Atopic Dermatitis have
impaired function of their skin barrier, which, combined with skin
damage as a result of the intense itching and scratching associated
with the disease, puts them at risk for secondary infections due to
colonization with pathogenic bacteria (particularly Staphylococcus
aureus) and changes in the skin microbiome. Atopic Dermatitis
affects an estimated 20 million people in the U.S., including up to
20% of children and up to 3% of adults, and prevalence continues to
increase.
About Acne
Acne Vulgaris is the most common chronic skin condition. The
disease can range from mild to severe cystic acne and is associated
with significant physical and psychosocial effects on quality of
life, including permanent scarring, depression and anxiety. Two of
the main factors involved in the development of Acne are clogged
pores and / or the presence of bacteria, leading to irritation,
lesions and inflammation. Studies have demonstrated a central role
of inflammation in the development of Acne lesions and have opened
new opportunities for therapeutic intervention that target
inflammation. Acne affects approximately 45 million people, or 14%
of the population, in the U.S. Analysts value the prescription
market for Acne at close to $4 billion in the United States in
2017, with continued growth expected.
About Psoriasis
Psoriasis is a common chronic autoimmune disorder of the skin
characterized by focal formation of inflamed, raised plaques that
constantly shed scales derived from excessive growth of skin
epithelial cells. Research has identified key cellular and
molecular pathways of inflammation that contribute to the
pathogenesis of Psoriasis. Approximately 12 million people in the
U.S. suffer from Psoriasis, of whom an estimated 7.5 million have
been diagnosed with the skin disease, and an estimated 50% to 60%
are actively being treated for the disease. Psoriasis is the
largest indication in dermatology with, according to analyst
estimates, approximately $6 billion in sales in the U.S. in 2017,
which can largely be attributed to biologics.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company
developing novel therapeutics that target the interplay between
innate and adaptive immunity. The Company's programs seek to
influence immune signaling and change the course of immune-mediated
diseases in adults and children. Realm's lead drug development
program utilizes the Company's proprietary immunomodulatory
technology for the treatment of Atopic Dermatitis, and the Company
is exploring its efficacy in other dermatology indications which
include Acne Vulgaris and Psoriasis, as well as other therapeutic
areas. For more information on Realm Therapeutics please visit
www.realmtx.com.
Forward Looking Statements
Certain statements made in this announcement are forward-looking
statements, including with respect to the Company's clinical trials
and product candidate development plans. These forward-looking
statements are not historical facts but rather are based on the
Company's current expectations, estimates, and projections about
its industry; its beliefs; and assumptions. Words such as
'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,'
'estimates,' and similar expressions are intended to identify
forward-looking statements. These statements are not guarantees of
future performance and are subject to known and unknown risks,
uncertainties, and other factors, some of which are beyond the
Company's control, are difficult to predict, and could cause actual
results to differ materially from those expressed or forecasted in
the forward-looking statements, including clinical developments and
regulatory review of product candidates. The Company cautions
shareholders and prospective shareholders not to place undue
reliance on these forward-looking statements, which reflect the
view of the Company only as of the date of this announcement. The
forward-looking statements made in this announcement relate only to
events as of the date on which the statements are made. The Company
will not undertake any obligation to release publicly any revisions
or updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
RNS-RLM
Contacts:
Realm Therapeutics plc
Alex Martin, Chief Executive Officer
Marella Thorell, Chief Financial Officer and Chief Operating
Officer
Outside US: +44 (0) 20 3727 1000
US: +1 212 600 1902
Argot Partners
Stephanie Marks / Susan Kim
+1 212 600 1902
FTI Consulting
Simon Conway / Mo Noonan
+44 (0) 20 3727 1000
N+1 Singer (Nominated Adviser and Broker)
Aubrey Powell / Jen Boorer
+44 (0) 20 7496 3000
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END
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