Realm Therapeutics PLC FDA Permits PR013 to Proceed to Phase II Trial (2996Q)
11 September 2017 - 4:00PM
UK Regulatory
TIDMRLM
RNS Number : 2996Q
Realm Therapeutics PLC
11 September 2017
Realm Therapeutics plc
("Realm Therapeutics", "Realm" or the "Company")
FDA Permits Realm Therapeutics' PR013 to Proceed to Phase II
Clinical Trial for Allergic Conjunctivitis
Trial expected to commence by end of year, top line read-out in
mid-2018
11 September 2017 - Realm Therapeutics plc (AIM: RLM), a
clinical stage biopharmaceutical company focused on leveraging its
proprietary immunomodulatory technology, is pleased to announce
that the US Food and Drug Administration (FDA) has permitted
Realm's IND application for PR013 to proceed into Phase II clinical
trials for the treatment of Allergic Conjunctivitis (AC).
The Phase II AC trial will be a multi-centre, double-blind,
randomized evaluation of the effectiveness of PR013 topical
ophthalmic drops compared to vehicle for the treatment of AC using
a modified Conjunctival Allergen Challenge Model (Ora-CAC(R)) in
approximately 90 patients conducted in the US. For the past three
decades, the Ora-CAC(R) model has been the accepted standard for
the successful development of novel treatments for AC in the US.
The majority of FDA approved treatments for AC used the Ora-CAC(R)
model as the basis for their approval. If clinical efficacy is
demonstrated in the Phase II trial, it could become one of the
Company's two pivotal trials needed for approval. Estimated peak
annual sales potential in this indication is approximately $400
million in the US, based on market analysis and data from
pre-clinical models.
PR013 is the Company's second lead candidate in a new class of
anti-inflammatory / immunomodulatory drugs utilising a high
concentration of hypochlorous acid as the active ingredient. The
Company previously announced that it was allowed to proceed to a
Phase II clinical trial of PR022 for Atopic Dermatitis (AD). Both
trials are expected to commence before the end of this year, with
top line data expected in mid-2018. On current plans and timelines,
the Company's' cash resources, which were $15.6 million as at 30
June 2017, are expected to be sufficient to fund both of these two
Phase II trials.
Alex Martin, Chief Executive Officer of Realm Therapeutics,
said:
"We are delighted that PR013 is now permitted to move into a
Phase II clinical trial. The product represents a promising novel
therapeutic approach for treating adults and children with Allergic
Conjunctivitis. There is a significant unmet medical need in AC,
particularly for the circa 30% of patients who are refractive to
the standard of care, antihistamines, and due to the significant
safety concerns with steroid treatments, including increased
intraocular pressure, which can lead to glaucoma.
"We have demonstrated in pre-clinical models that PR013 has
similar efficacy to high-dose steroids. If successful in this and
future studies, PR013 will provide a safe and effective alternative
to current therapies. We are very pleased to be in a position to
move this important new therapy into the clinic later this year,
along with our PR022 trial for Atopic Dermatitis, which will also
commence before the end of the year, and look forward to reporting
data from both in 2018."
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
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. Approximately 30%
of AC patients do not adequately respond to the current standard of
care.
About Ora, Inc.
Ora is a leading full-service ophthalmic CRO. Over the past 40
years, Ora has helped its clients earn 45 product approvals. Ora
supports a wide array of organizations, from startups to global
pharmaceutical and device companies, to efficiently and
successfully bring their new products from concept to market. Ora's
pre-clinical and clinical models, unique methodologies and
regulatory strategies have been refined and proven across thousands
of projects both in the US and internationally. Ora brings together
the world's most extensive and experienced network of ophthalmic
experts and R&D professionals to maximize the value of new
product initiatives. Learn more at www.oraclinical.com
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
MSCLLFIDAIIILID
(END) Dow Jones Newswires
September 11, 2017 02:00 ET (06:00 GMT)
Realm Thera. (LSE:RLM)
Historical Stock Chart
From Apr 2024 to May 2024
Realm Thera. (LSE:RLM)
Historical Stock Chart
From May 2023 to May 2024