MALVERN, Pa., Dec. 5, 2017 /PRNewswire/ -- 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 EASI1 and
IGA2, 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."
1Eczema 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
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SOURCE Realm Therapeutics