TIDMRLM
RNS Number : 6495O
Realm Therapeutics PLC
21 May 2018
Realm Therapeutics Presents Data Highlighting its Proprietary
Immunomodulatory Technology's Potential in Acne and Psoriasis at
IID 2018
MALVERN, PA, May 21, 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 presented a poster at the 2018 International
Investigative Dermatology (IID) Meeting in Orlando, Florida.
The poster, titled "Potential New Treatment for Acne and
Psoriasis: PR022 Inhibits IL-1<BETA> in vitro and in a Model
of Dermal Hypersensitivity in a Dose-Dependent Manner," was
presented at IID on May 19 by Ethan Solomon, PhD, Director of
Research and Development at Realm.
"We have demonstrated that hypochlorus acid (HOCl) at high
concentrations acts as an immunomodulatory agent, capable of down
regulating many key cytokines associated with inflammation and
disease," commented Alex Martin, CEO at Realm. "These results
indicate that Realm's proprietary formulation of high concentration
HOCl, may be a clinically meaningful treatment for Psoriasis and
Acne Vulgaris, two diseases with elevated lesion levels of
IL-1<BETA>."
In this study, the immunomodulatory effect of PR022 was studied
in vitro in human peripheral blood mononuclear cells (PBMC) and in
a murine hypersensitivity model, Toluene diisocaynate (TDI).
Treatment of PBMC with HOCl resulted in significant, dose-dependent
reduction in IL-1<BETA>. In the TDI model, application of
PR022 reduced swelling and IL-1<BETA> levels in ear skin
tissue after TDI challenge. In addition, PR022 significantly
reduced the number of scratching bouts after TDI challenge,
indicating a potential benefit in pruritus, a significant symptom
of Atopic Dermatitis, Acne, Psoriasis, and other dermatologic
diseases.
About PR022
PR022 is a proprietary, non-alcohol based, topical gel
formulation of high concentration HOCl, 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 a statistically
significant therapeutic effect, including 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.
PR022 is currently being studied in a Phase 2 clinical trial in
the U.S, with top line data expected in Q3 2018. 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 and are correlated to
disease severity. The Company intends to file an Investigational
New Drug (IND) application to study PR022 in Psoriasis in Q1,
2019.
About RLM023
RLM023 is a topical formulation of HOCl that is being optimized
for Acne. Realm believes that an 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. The Company intends to
file an IND application in Q4, 2018 to support entry into a Phase 2
clinical trial and, pending FDA clearance, to initiate a Phase 2
proof of concept study in the first quarter of 2019.
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
Contact:
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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