12 Dec 2017 07:00
Realm Therapeutics Announces First Patient Dosed in Phase 2 Study of PR013 for the Treatment of Allergic Conjunctivitis
MALVERN, PA, December 12 2017 - Realm Therapeutics plc (AIM:RLM), a clinical stage biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, today announces the first patient has been dosed in its Phase 2 study of PR013, the Company's topical ophthalmic formulation of high concentration hypochlorous acid, for the treatment of allergic conjunctivitis. The study is being conducted in the United States and top line data is expected in Q2 2018.
The study is a multi-center, double-blind, randomized evaluation of the effectiveness of PR013 topical ophthalmic solution compared to vehicle for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®) in approximately 90 patients. The Ora-CAC® model has been the accepted standard for the successful development of novel treatments for allergic conjunctivitis in the U.S. for the past three decades.
"With the initiation of our second Phase 2 study in as many weeks, we continue to build out our immunomodulatory pipeline and move one step closer to bringing new treatments to patients" said Alex Martin, Chief Executive Officer of Realm. "Allergic conjunctivitis affects up to 40% of the U.S. population but the current standards of care, steroids and anti-histamines, have significant safety and efficacy shortcomings for patients. In preclinical models, PR013 has demonstrated similar efficacy to high-dose steroids in reducing the redness associated with allergic conjunctivitis, and in reducing itch from both histaminergic and non-histaminergic pathways. Harnessing Realm's proprietary high concentrations of hypochlorous acid, PR013 has the potential to be a novel, safe and effective treatment alternative for patients suffering from allergic conjunctivitis. We look forward to the results of this study in the second quarter of next year."
About Allergic Conjunctivitis
Allergic conjunctivitis is an ophthalmic disease characterized by inflammation of the conjunctiva as a result of contact with airborne allergens. It can be divided into two main categories:
· Seasonal, the most common form which follows a more predictable course that coincides with seasonal increases in allergens (e.g. pollen) and with less dramatic onset (develops over days to weeks); and
· Perennial, a chronic waxing and waning of reaction due to year round allergen exposure (e.g. dust mites, dander, and molds).
Allergic conjunctivitis affects up to 40% of the U.S. population and up to 20% of the population of Europe and Japan, including children. Prominent symptoms include bilateral ocular pruritus, redness, and eyelid edema; watery discharge, burning, and photophobia can also occur. The disease also has associated nasal symptoms.
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