Realm Therapeutics PLC First Patient Dosed in Phase 2 Study of PR022 (3601Y)
December 05 2017 - 1:00AM
UK Regulatory
TIDMRLM
RNS Number : 3601Y
Realm Therapeutics PLC
05 December 2017
Realm Therapeutics Announces First Patient Dosed in Phase 2
Study of PR022 for the Treatment of Atopic Dermatitis
MALVERN, PA, 5 December 2017 - Realm Therapeutics plc (AIM:RLM),
a clinical stage biopharmaceutical company focused on leveraging
its proprietary immunomodulatory technology, today announced the
first patient has been dosed in its Phase 2 study of PR022, the
Company's proprietary topical gel formulation of high concentration
hypochlorous acid, for the treatment of atopic dermatitis. The
trial is being conducted in the United States and top line data is
expected in Q3 2018.
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 approximately 120
adult patients with mild-to-moderate atopic dermatitis. Multiple
endpoints will be explored, including EASI(1) and IGA(2) , as well
as additional assessments of pruritus and quality of life.
"We are extremely pleased to have initiated our first Phase 2
study, which represents a significant milestone for Realm as we
continue to execute on our strategy," said Alex Martin, Chief
Executive Officer of Realm. "Recently published peer reviewed
research has demonstrated PR022's ability to prevent the
development of atopic dermatitis-like lesions, reduce existing
lesions and associated scratching, and reduce the inflammatory
response. PR022 could offer an important alternative to patients
suffering from atopic dermatitis and we are very excited about the
potential of this new therapy."
(1) Eczema Area and Severity Index (EASI) is an
investigator-assessed tool used to measure the extent (area) and
severity of atopic eczema.
(2) Investigator Global Assessment (IGA), is an
investigator-assessed instrument measuring severity of atopic
dermatitis on a 5 grade scale.
About Atopic Dermatitis
Atopic dermatitis, a serious form of eczema, is a chronic,
relapsing, inflammatory disease characterised by itchy, inflamed
skin, which poses a significant burden on patients' quality of life
and on the overall health care system. Patients with atopic
dermatitis have impaired function of their skin barrier, and this,
combined with skin damage as a result of the intense itching and
scratching associated with the disease, makes them at risk for
secondary infections due to colonisation with pathogenic bacteria
(particularly Staphylococcus aureus) and changes in the skin
microbiome. Atopic dermatitis affects up to 20% of children and up
to 3% of adults and prevalence numbers continue to increase.
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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