MALVERN, Pa., May 24, 2018 /PRNewswire/ -- 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-α, 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-α, IL-1β, 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.
G-RLM
View original
content:http://www.prnewswire.com/news-releases/realm-therapeutics-completes-enrollment-in-phase-2-study-of-pr022-for-atopic-dermatitis-300653860.html
SOURCE Realm Therapeutics