MALVERN, PA, USA I August 14, 2018 I Realm Therapeutics plc (NASDAQ:RLM / AIM:RLM), a clinical stage biopharmaceutical company focused on developing novel therapeutics in immune-mediated diseases, today reports preliminary top-line data from its Phase 2 trial of PR022 in Atopic Dermatitis, as well as financial results for the six months ended June 30, 2018.

In a randomized, double-blind, vehicle controlled, Phase 2 clinical trial of 122 patients, PR022 showed no difference from vehicle in the primary endpoint of percent change in Eczema Area Severity Index (EASI) versus baseline. 

“PR022 did not show the desired effect in this trial,” said Alex Martin, CEO of Realm Therapeutics. “Having just received the data, we are working to better understand this outcome and to analyze all of the data collected in the study.  We are conducting a full review to determine whether there is a path forward for our proprietary technology in Atopic Dermatitis, and to evaluate the implications for our Acne and Psoriasis programs. We will provide an update on our plans in September. I would like to thank the patients and investigators who participated in this trial.”

CORPORATE AND FINANCIAL HIGHLIGHTS

  • Cash, cash equivalents and short-term investments were $23.7 million at June 30, 2018 (at December 31, 2017: $33.9m).
  • Investments in Research & Development increased to $7.4 million (H1 2017: $3.0m) driven by increased investment in clinical development activities.
  • General and Administrative expenses increased to $3.5 million (H1 2017: $1.6m) primarily due to Nasdaq listing costs.
  • In July 2018, Realm listed American Depositary Shares (ADSs) representing the Company’s ordinary shares on the Nasdaq Capital Market to facilitate the creation of a trading market in the US for the Company’s securities and in satisfaction of obligations under a registration rights agreement entered into with investors who participated in the Company’s October 2017 private placement.
  • The US Patent and Trademark Office issued two new patents to Realm that expand the intellectual property portfolio around the Company’s proprietary immunomodulatory technology in the treatment of inflammatory and autoimmune disorders.

Availability of Other Information

The Company has submitted a Form 6-K to the Securities and Exchange Commission (SEC) which includes as exhibits: Unaudited Financial Statements and Notes prepared on a US GAAP basis, Management’s Discussion & Analysis, Risk Factors related to the business and a copy of this press release.  These documents can be accessed from the Investor section of the Company’s website at www.realmtx.com

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 signalling 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.

Pipeline

PR022 is a proprietary, non-alcohol based, topical gel formulation of high concentration hypochlorous acid (HOCl).  Realm is evaluating PR022 for potential application in Atopic Dermatitis and Psoriasis.  RLM023 is a topical formulation of HOCl that is being optimized and evaluated for Acne Vulgaris.

SOURCE: Realm Therapeutics