RLM.L Regulatory News (RLM)

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®) in approximately 90 patients conducted in the US. For the past three decades, the Ora-CAC® 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® 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:

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.