RLM.L Regulatory News (RLM)

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®) in approximately 90 subjects. For the past three decades, the Ora-CAC® 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® 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."

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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.