Realm Therapeutics PLC First Patient Dosed in Phase 2 Study of PR013 (0227Z)
December 12 2017 - 1:00AM
UK Regulatory
TIDMRLM
RNS Number : 0227Z
Realm Therapeutics PLC
12 December 2017
Realm Therapeutics Announces First Patient Dosed in Phase 2
Study of PR013 for the Treatment of Allergic Conjunctivitis
MALVERN, PA, December 12 2017 - Realm Therapeutics plc
(AIM:RLM), a clinical stage biopharmaceutical company focused on
leveraging its proprietary immunomodulatory technology, today
announces the first patient has been dosed in its Phase 2 study of
PR013, the Company's topical ophthalmic formulation of high
concentration hypochlorous acid, for the treatment of allergic
conjunctivitis. The study is being conducted in the United States
and top line data is expected in Q2 2018.
The study is a multi-center, double-blind, randomized evaluation
of the effectiveness of PR013 topical ophthalmic solution compared
to vehicle for the treatment of allergic conjunctivitis using a
modified Conjunctival Allergen Challenge Model (Ora-CAC(R)) in
approximately 90 patients. The Ora-CAC(R) model has been the
accepted standard for the successful development of novel
treatments for allergic conjunctivitis in the U.S. for the past
three decades.
"With the initiation of our second Phase 2 study in as many
weeks, we continue to build out our immunomodulatory pipeline and
move one step closer to bringing new treatments to patients" said
Alex Martin, Chief Executive Officer of Realm. "Allergic
conjunctivitis affects up to 40% of the U.S. population but the
current standards of care, steroids and anti-histamines, have
significant safety and efficacy shortcomings for patients. In
preclinical models, PR013 has demonstrated similar efficacy to
high-dose steroids in reducing the redness associated with allergic
conjunctivitis, and in reducing itch from both histaminergic and
non-histaminergic pathways. Harnessing Realm's proprietary high
concentrations of hypochlorous acid, PR013 has the potential to be
a novel, safe and effective treatment alternative for patients
suffering from allergic conjunctivitis. We look forward to the
results of this study in the second quarter of next year."
About Allergic Conjunctivitis
Allergic conjunctivitis is an ophthalmic disease characterized
by inflammation of the conjunctiva as a result of contact with
airborne allergens. It can be divided into two main categories:
-- Seasonal, the most common form which follows a more
predictable course that coincides with seasonal increases in
allergens (e.g. pollen) and with less dramatic onset (develops over
days to weeks); and
-- Perennial, a chronic waxing and waning of reaction due to
year round allergen exposure (e.g. dust mites, dander, and
molds).
Allergic conjunctivitis affects up to 40% of the U.S. population
and up to 20% of the population of Europe and Japan, including
children. Prominent symptoms include bilateral ocular pruritus,
redness, and eyelid edema; watery discharge, burning, and
photophobia can also occur. The disease also has associated nasal
symptoms.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company
focused on developing novel immunomodulatory therapies to protect
and improve the lives of adults and children. The Company has
initiated drug development programs, based on its proprietary
hypochlorous acid technology at high concentrations. The Company
believes its formulations have novel immunomodulatory activity with
potential application for the treatment of diseases in a number of
therapeutic areas, including Dermatology and Ophthalmology.
Forward Looking Statements
Certain statements made in this announcement are forward-looking
statements. 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.
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.
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
+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 company news service from the London Stock Exchange
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