TIDMPURI
RNS Number : 2734P
PuriCore Plc
16 November 2016
PuriCore plc
("PuriCore" or the "Company")
PuriCore expects to initiate two Phase II clinical trials in
2017
PuriCore to rename as Realm Therapeutics
Positive feedback from FDA sets clear path for Allergic
Conjunctivitis programme; new data presented today enhances Atopic
Dermatitis rationale
16 November 2016 - PuriCore plc (AIM: PURI), an emerging
specialty biopharmaceutical company focused on leveraging its
proprietary immunomodulatory technology, is pleased to provide the
following updates on its key development programmes, both of which
leverage the Company's patented hypochlorous acid formulations.
PR013, being developed for the treatment of Allergic
Conjunctivitis(*) :
-- The Company successfully completed a pre-Investigational New
Drug (IND) meeting with the U.S. Food and Drug Administration (FDA)
on PR013, which validated plans to enter a Phase II trial following
submission of the IND.
-- The Company plans to submit the IND application for PR013 in
Q3 2017 and to initiate the clinical trial in 2017.
-- PR013 is a proprietary topical ophthalmic solution containing
high concentrations of hypochlorous acid as the active moiety.
-- The Company has demonstrated that PR013 is associated with a
statistically significant therapeutic effect in established animal
models of Allergic Conjunctivitis.
PR022, being developed for Atopic Dermatitis(**) :
-- Pre-clinical data on PR022 for Atopic Dermatitis, noting
significant reduction of key cytokines associated with the disease,
including IL4, IL13, IL-31 and TARC, and serum IgE, is being
presented today at the Inflammatory Skin Disease Summit in New York
City.
-- Following the successful pre-IND meeting with the FDA in
June, the Company's plans remain to submit an IND application for
PR022 in Q1 2017 and to begin a Phase II trial shortly
thereafter.
-- PR022 is a proprietary topical gel also containing hypochlorous acid as the active moiety.
-- The Company has demonstrated that PR022 is associated with a
statistically significant therapeutic effect in established animal
models of Atopic Dermatitis.
* Allergic Conjunctivitis, or ocular allergy, is an
immune-mediated disease characterized by itching, redness, burning,
and tearing of the eye which affects at least 20% of the population
globally.
** Atopic Dermatitis (AD) is a chronic inflammatory skin disease
which poses a significant burden on patients' quality of life and
on the overall health care system. AD affects up to 20% of children
and up to 3% of adults and prevalence numbers continue to
increase.
As at 31 October 2016, cash and cash equivalents were $23.7
million (30 June 2016: $12.8 m), reflecting receipt of the gross
proceeds from the sale of the Supermarket Retail business, less
certain deal-related costs. Investments are expected to accelerate
in 2017 as two IND applications are filed and clinical trials begin
and as the remaining deal costs are paid.
In addition, the Company today announces its intention to change
its name to Realm Therapeutics to more accurately reflect the
Company's strategic focus and direction. The change is expected to
be effective by year-end and a further announcement will be made at
the appropriate time.
Alex Martin, Chief Executive Officer of PuriCore, said:
"The completed disposal of the Supermarket Retail business has
generated additional funds to progress our two lead candidates into
clinical trials. The intended change of the Company's name to Realm
Therapeutics signifies our sole focus on drug development as an
emerging specialty biopharmaceutical company.
"We are extremely pleased with our continued progress and are
excited to share further developments related to our two
candidates, PR013 and PR022, including the timelines for submission
of the two INDs, and initiation of two Phase II clinical trials in
2017. We look forward to providing further updates in due
course."
Enquiries:
+44 (0) 20 3727
PuriCore 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 / Jen Boorer
About PuriCore
PuriCore is an emerging specialty 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 their 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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November 16, 2016 02:00 ET (07:00 GMT)
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