RLM.L Regulatory News (RLM)

Realm Therapeutics Presents Data Highlighting its Proprietary Immunomodulatory Technology's Potential in Acne and Psoriasis at IID 2018

MALVERN, PA, May 21, 2018 - Realm Therapeutics plc (AIM:RLM), a clinical stage biopharmaceutical company focused on developing novel therapeutics in immune-mediated diseases, today announces that the Company presented a poster at the 2018 International Investigative Dermatology (IID) Meeting in Orlando, Florida.

The poster, titled "Potential New Treatment for Acne and Psoriasis: PR022 Inhibits IL-1β in vitro and in a Model of Dermal Hypersensitivity in a Dose-Dependent Manner," was presented at IID on May 19 by Ethan Solomon, PhD, Director of Research and Development at Realm.  

"We have demonstrated that hypochlorus acid (HOCl) at high concentrations acts as an immunomodulatory agent, capable of down regulating many key cytokines associated with inflammation and disease," commented Alex Martin, CEO at Realm. "These results indicate that Realm's proprietary formulation of high concentration HOCl, may be a clinically meaningful treatment for Psoriasis and Acne Vulgaris, two diseases with elevated lesion levels of IL-1β."

In this study, the immunomodulatory effect of PR022 was studied in vitro in human peripheral blood mononuclear cells (PBMC) and in a murine hypersensitivity model, Toluene diisocaynate (TDI). Treatment of PBMC with HOCl resulted in significant, dose-dependent reduction in IL-1β. In the TDI model, application of PR022 reduced swelling and IL-1β levels in ear skin tissue after TDI challenge. In addition, PR022 significantly reduced the number of scratching bouts after TDI challenge, indicating a potential benefit in pruritus, a significant symptom of Atopic Dermatitis, Acne, Psoriasis, and other dermatologic diseases.

About PR022

PR022 is a proprietary, non-alcohol based, topical gel formulation of high concentration HOCl, offering a differentiated mechanism of action for the treatment of Atopic Dermatitis. In pre‑clinical models of Atopic Dermatitis, the Company has demonstrated that PR022 is associated with a statistically significant therapeutic effect, including down modulation of key cytokines IL-4, IL-13 and TARC, as well as cytokines associated with itch, including IL-31 and TSLP. Importantly, these results were demonstrated without the typical immunosuppressive impact of steroids, the current standard of care, suggesting a potential clinical advantage for PR022.

PR022 is currently being studied in a Phase 2 clinical trial in the U.S, with top line data expected in Q3 2018. Realm is also evaluating PR022 for Psoriasis. Pre-clinical studies have shown in vitro and in vivo that HOCl can down modulate key cytokines TNF-α, IL-6, and IL-12, which have been reported at elevated levels in patients with Psoriasis and are correlated to disease severity. The Company intends to file an Investigational New Drug (IND) application to study PR022 in Psoriasis in Q1, 2019.

About RLM023

RLM023 is a topical formulation of HOCl that is being optimized for Acne. Realm believes that an HOCl based formulation may offer a promising treatment for Acne due to its anti-inflammatory and anti-microbial properties. In in vitro and in vivo pre-clinical studies, HOCl demonstrated, a reduction in the expression of pro-inflammatory cytokines such as TNF-α, IL 1β, Il-8 and IL-12, which have been reported to be key cytokines associated with Acne pathogenesis. The Company intends to file an IND application in Q4, 2018 to support entry into a Phase 2 clinical trial and, pending FDA clearance, to initiate a Phase 2 proof of concept study in the first quarter of 2019.

About Realm Therapeutics

Realm Therapeutics is a clinical-stage biopharmaceutical company developing novel therapeutics that target the interplay between innate and adaptive immunity. The Company's programs seek to influence immune signaling and change the course of immune-mediated diseases in adults and children. Realm's lead drug development program utilizes the Company's proprietary immunomodulatory technology for the treatment of Atopic Dermatitis, and the Company is exploring its efficacy in other dermatology indications which include Acne Vulgaris and Psoriasis, as well as other therapeutic areas. For more information on Realm Therapeutics please visit www.realmtx.com.

Forward Looking Statements

Certain statements made in this announcement are forward-looking statements, including with respect to the Company's clinical trials and product candidate development plans. 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, including clinical developments and regulatory review of product candidates. 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.

RNS-RLM

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 / Susan Kim

+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