MALVERN, Pa., May 21, 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 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-1β 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-1β."
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-1β. In the TDI model, application of PR022 reduced
swelling and IL-1β 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-α, 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-α, IL 1β, 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.
G-RLM
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SOURCE Realm Therapeutics