9 Jun 2016 07:00
PuriCore plc
("PuriCore" or the "the Company")
PuriCore successfully completes Pre-IND Meeting with the FDA on PR022 for Atopic Dermatitis
IND to be filed in Q1 2017, in line with previous guidance
9 June 2016 - PuriCore plc (AIM: PURI), an emerging specialty biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, today announces that it has successfully completed a pre-Investigational New Drug Application (Pre-IND) Meeting with the U.S. Food and Drug Administration (FDA) for its lead candidate PR022, which is being developed for the treatment of Atopic Dermatitis.
The Company announced in February a new strategic focus on drug development of novel therapies in Dermatology, Ophthalmology and potentially rare diseases. This successful meeting paves the way for submission of the first IND application to the FDA for Atopic Dermatitis, earmarked for Q1 2017.
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. PR022 is a proprietary topical hydrogel where the active moiety is hypochlorous acid. The Company has demonstrated that PR022, a patented high dose concentration of hypochlorous acid, is associated with a statistically significant therapeutic effect in animal models of dermatitis. PR022 leverages the Company's patented technology for the generation and stabilization of hypochlorous acid solutions.
Alex Martin, Chief Executive Officer of PuriCore, said:
"We are extremely pleased with the progress we have made in advancing our new strategic focus as an emerging specialty pharmaceutical company and the development plans for our platform technology remain on track. The successful completion of our Pre-IND Meeting for PR022 builds on a continuing, constructive dialogue with the FDA. We are confident that our IND will be filed on schedule by Q1 2017, and that our clinical trial plan will be straightforward."
Enquiries:
PuriCore plc | +44 (0) 20 3727 1000 |
Alex Martin, Chief Executive Officer | |
Marella Thorell, Chief Financial Officer and Chief Operating Officer | |
FTI Consulting | +44 (0) 20 3727 1000 |
Simon Conway / Mo Noonan / Victoria Foster Mitchell | |
N+1 Singer (Nominated Adviser and Broker) | +44 (0) 20 7496 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 a drug development program, 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 such as Dermatology, Ophthalmology and potentially rare diseases.
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.