TIDMRLM
Realm Therapeutics PLC
10 July 2018
Realm Therapeutics Announces Publication of Pre-Clinical Study
Demonstrating Comparable Activity of PR022 and Topical Tofacitinib
in the Treatment of Atopic Dermatitis
MALVERN, PA, July 10, 2018 - Realm Therapeutics plc (NASDAQ:RLM
/ AIM:RLM), a clinical stage biopharmaceutical company focused on
developing novel therapeutics in immune-mediated diseases, today
announces the publication of a pre-clinical study demonstrating
comparable activity between PR022, Realm's proprietary topical gel
formulation of high concentration hypochlorous acid (HOCl), and
tofacitinib, a topical Janus kinase (JAK) inhibitor, in the
treatment of Atopic Dermatitis. The article, "Comparison of topical
tofacitinib and 0.1% hypochlorous acid in a murine atopic
dermatitis model" was published in the current issue of BMC
Pharmacology and Toxicology.
Researchers compared the effect of topical administration of
PR022 and tofacitinib on Atopic Dermatitis-like lesions and itch
behavior in a widely accepted NC/Nga mouse model. PR022 and
tofacitinib showed similar reductions in skin lesions, scratching
behavior, concentrations of IL-4, IL-13, TARC and TSLP, serum IgE
and sensory nerve activation in dorsal root ganglia. In addition to
efficacy comparisons, the study demonstrated that PR022 in 0.1%
concentration was well tolerated. PR022 and tofacitinib are both
currently in clinical studies for treatment of Atopic Dermatitis.
The full publication can be accessed here.
"This study reinforces our belief in PR022's potential for
patients suffering from Atopic Dermatitis," said Alex Martin, Chief
Executive Officer of Realm. "PR022 demonstrated anti-inflammatory
and anti-itch properties in an animal model of the disease,
comparable to the investigational JAK inhibitor in the study. In
this study and others, PR022 has been well tolerated, which we
believe could make it useful for the large pediatric segment of the
Atopic Dermatitis patient population. We look forward to sharing
the top line results from our Phase 2 clinical study of PR022 in
Atopic Dermatitis later this quarter."
In May, Realm announced that it had completed enrollment in its
Phase 2 study of PR022 for the treatment of Atopic Dermatitis. The
randomized, double-blind, vehicle-controlled, multicenter,
parallel-group study is being conducted in the United States and is
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 (itching) and quality of
life.
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 occurred without the same
immunosuppressive or other side effects associated with steroids,
the current standard of care, suggesting a potential clinical
advantage for PR022.
Realm is also evaluating its proprietary HOCl formulations in
other indications including Acne Vulgaris and Psoriasis.
Pre-clinical studies have shown in vitro and in vivo that HOCl can
down modulate key cytokines such as TNF-<ALPHA> , IL1 ,
IFN-<GAMMA> , Il-8 and IL-12, which have been reported to be
associated with Acne pathogenesis and TNF-<ALPHA>, IL-6, and
IL-12, which have been reported at elevated levels in patients with
Psoriasis.
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. Analysts estimate that this market will grow to
approximately $5 billion, excluding steroids, in the United States
by 2022 driven by recent product approvals.
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 signalling 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 / Claudia Styslinger
+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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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(END) Dow Jones Newswires
July 10, 2018 02:00 ET (06:00 GMT)
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