Realm Therapeutics PLC Submission of Investigational New Drug Application (8208M)
August 02 2017 - 2:00AM
UK Regulatory
TIDMRLM
RNS Number : 8208M
Realm Therapeutics PLC
02 August 2017
Realm Therapeutics plc
("Realm Therapeutics", "Realm" or the "Company")
Realm Therapeutics Submits Investigational New Drug Application
for PR013 for Allergic Conjunctivitis
Second IND submission for Company this year
2 August 2017 - Realm Therapeutics plc (AIM: RLM), a clinical
stage biopharmaceutical company focused on leveraging its
proprietary immunomodulatory technology, is pleased to announce the
submission of its second investigational new drug (IND) application
to the U.S. Food and Drug Administration (FDA) for PR013, as a
novel treatment for allergic conjunctivitis (AC). Pending
clearance, the IND will enable Realm to initiate a Phase II trial
in the U.S. for patients aged 10 years and older with allergic
conjunctivitis.
The Phase II trial will be a multi-center, double-blind,
randomized, evaluation of the effectiveness of PR013 topical
ophthalmic drops compared to vehicle for the treatment of allergic
conjunctivitis using a modified Conjunctival Allergen Challenge
Model (Ora-CAC(R)) in approximately 90 subjects. For the past three
decades, the Ora-CAC(R) model has been the accepted standard for
the successful development of novel treatments of AC in the U.S.
The majority of the currently FDA approved treatments for AC used
the Ora-CAC(R) model as the basis for the approval.
PR013 is a proprietary topical formulation, in which the active
moiety is a patented high concentration of hypochlorous acid,
offering a differentiated mechanism of action for the treatment of
a significant disease. As previously announced, the Company has
shown that PR013 is associated with a statistically significant
therapeutic effect on hyperemia (ocular redness) in animal models
of allergic conjunctivitis, superior to olopatadine (0.1%) and
similar to prednisolone (1%).
The Company has also shown that the active moiety in PR013
(which is the same active moiety in PR022, the Company's IND for
atopic dermatitis (AD) which is cleared to move into Phase II
trials) is associated with a statistically significant down
modulation of key pro-inflammatory cytokines and reduced expression
of Th2 cytokines, IL-4, IL-13, as well as IL-31 and TSLP, which are
associated with itch. AC and AD have similar etiology.
Ocular itch, a significant disruptive symptom of AC, is driven
by both histamine-dependent and histamine-independent pathways.
Standard of care treatment (antihistamines) focus on
histamine-dependent itch only. In vitro studies conducted by the
Company have shown PR013's ability to inhibit neuronal signaling
associated with both histaminergic and non-histaminergic itch,
suggesting its potential to alleviate both forms of ocular itch and
addressing an unmet need for the approximately 30% of AC patients
who do not adequately respond to the current standard of care.
Importantly, these in vivo and in vitro results are delivered
without the typical negative effects of commonly used AC and AD
immunomodulatory or immunosuppressant drugs, including
corticosteroids, suggesting an advantageous safety profile for
PR013. Based on market analysis and indications of superiority to
standard of care demonstrated in pre-clinical models, the Company
estimates that peak year sales potential for PR013 could reach
approximately $400 million in the U.S. market.
Alex Martin, Chief Executive Officer of Realm Therapeutics,
said:
"This is our second IND filing in six months, and we are very
pleased with the progress we have made following the announcement
of our drug development strategy last year. This submission
represents an important milestone and delivers on our commitment to
submit two INDs this year. Following FDA clearance, we expect to
begin the Phase II study later this year and to review the
subsequent data on PR013's efficacy as a potential novel treatment
for allergic conjunctivitis in the first half of 2018. If
successful in clinical studies, PR013 will potentially provide a
superior product to antihistamines and a safe and effective
alternative to topical steroids, for children and adults suffering
from this disease. Additionally, we remain on track to commence a
Phase II study for PR022 in atopic dermatitis later this year."
Enquiries:
+44 (0) 20 3727
Realm Therapeutics plc 1000
Alex Martin, Chief Executive Officer
Marella Thorell, Chief Financial
Officer and Chief Operating Officer
+44 (0) 20 3727
FTI Consulting 1000
Simon Conway / Mo Noonan /Ciara Martin
N+1 Singer (Nominated Adviser and +44 (0) 20 7496
Broker) 3000
Aubrey Powell / Lauren Kettle
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 programmes, 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.
About Allergic Conjunctivitis (AC)
AC is an inflammatory disease of the conjunctiva, the membrane
covering the white part of the eye, caused primarily from a
reaction to an allergen such as pollen, or pet dander, or other
environmental antigens, and affects up to 40% of the United States
population and up to 20% of the population of Europe and Japan,
including children. This inflammation results in redness, acute
itching, tearing and associated nasal symptoms.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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