SOURCE: Realm Therapeutics

February 28, 2017 14:34 ET

Realm Therapeutics: FDA permits PR022 to Proceed to Phase 2 Trial

MALVERN, PA--(Marketwired - Feb 28, 2017) - Realm Therapeutics (AIM: RLM)

Realm Therapeutics plc
("Realm Therapeutics", "Realm" or the "Company")

FDA Permits Realm Therapeutics to Proceed to Phase II Clinical Trial with PR022 for Atopic Dermatitis

Company Presents New Preclinical Data at Dermatology Innovation Forum

Notice of Results

28 February 2017 - Realm Therapeutics plc (AIM: RLM), an emerging specialty biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, is pleased to announce:

  • The US Food and Drug Administration (FDA) has permitted Realm's Investigational New Drug (IND) application to proceed into Phase II clinical trials with its lead drug candidate PR022, for the treatment of atopic dermatitis (AD)
  • Two posters will be presented at this week's Dermatology Innovation Forum in Florida, including pre-clinical models showing significant anti-itch properties and in vitro data elucidating the mechanism of action and supporting the linkage between the active ingredient in PR022 (a high concentration of hypochlorous acid) and reduced expression of protein markers associated with atopic dermatitis and related inflammation
  • Full year results to 31 December 2016 are expected to be released on 23 March 2017

FDA permits Phase II clinical trial for PR022 to proceed

The FDA has allowed the Company's IND application for a Phase II clinical trial with PR022 for atopic dermatitis (AD) to proceed. PR022 is the first candidate in a new class of anti-inflammatory / immunomodulatory topical gels for the treatment of AD, containing a high, stable concentration of hypochlorous acid. The trial will be a randomized, double-blind, vehicle-controlled, multicentre, parallel-group study to assess the safety and efficacy of multiple doses of PR022 in 120 adult patients with mild-to-moderate AD. The Company expects to begin the trial in the second half of this year. Further information will be available at clinicaltrials.gov in due course.

If successful in subsequent Phase II and pivotal clinical trials, and subject to receiving regulatory approval, Realm believes that peak year sales for PR022 could potentially reach or exceed $1.0 billion in the US market alone, based on market analysis conducted for the Company. This includes use of the product in the treatment of both adult and paediatric patients with mild-to-moderate disease. 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.

Poster presentations of pre-clinical and in vitro data for PR022 in AD

In addition, Realm will have two posters presented this week at the Dermatology Innovation Forum, coinciding with the American Academy of Dermatology Annual Meeting in Orlando, Florida. The first poster addresses the significant anti-itch properties of PR022, including a possible neuronal effect, as demonstrated in pre-clinical models of AD through research conducted by Dr. W Baeumer at North Carolina State. The second poster further elucidates the molecule's unique mechanism of action as an NF-κB inhibitor via IκBα as shown in in vitro studies conducted by Realm's scientific team. This study, is in addition to previously reported data showing down modulation and reduced expression of key cytokines, IL-4, IL-13, IL-31, TARC and TSLP, associated with the signs and symptoms of the disease. Abstracts of the posters will be available on the conference website and posters are available upon request from the Company.

Expected financial results date

The Company expects to release its Full Year Results for the year ended 31 December 2016 on 23 March 2017, and will hold a conference call that day. As at 31 December 2016, cash and cash equivalents were $21.4 million, reflecting the proceeds from the sale of the Supermarket Retail business.

Alex Martin, Chief Executive Officer of Realm Therapeutics, said:

"PR022 represents a promising novel therapeutic approach for treating atopic dermatitis, where there exists a significant unmet medical need. We are very pleased to be in a position to move this therapy into clinical development later this year. The data we are presenting at the Dermatology Innovation Forum relates to the product's anti-itch properties, which is significant as the disease is associated with chronic sleep disturbances due to itching, particularly in children; and its mechanism of action, showing our product's ability to regulate cellular responses to inflammation via inhibition of NF-κB, which has been widely implicated in inflammatory diseases and innate immunity.

"In addition, we remain on track to file our PR013 IND for allergic conjunctivitis in Q3 this year. On current projections, we have sufficient cash to fund Phase II clinical trials for both PR022 and PR013, and we look forward to reporting further progress in due course."

Enquiries:

Realm Therapeutics 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    
     
N+1 Singer (Nominated Adviser and Broker)   +44 (0) 20 7496 3000
Aubrey Powell / Lauren Kettle    

This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014 (MAR).

About Realm Therapeutics

Realm Therapeutics 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 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.

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