30 Jan 2017 07:00
Realm Therapeutics plc
("Realm Therapeutics", "Realm" or the "Company")
Realm Therapeutics Submits Investigational New Drug Application for PR022 for Atopic Dermatitis
Key milestone in Company's drug development programme
30 January 2017 - Realm Therapeutics plc (AIM: RLM), an emerging specialty biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, is pleased to announce submission of its first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for PR022, as a novel treatment for atopic dermatitis (AD). Pending acceptance, the IND will enable Realm to initiate a Phase 2a proof-of-concept trial for patients with atopic dermatitis.
The Phase 2a 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 adult patients with mild-to-moderate AD. Based on outcomes of this study, the Company intends to conduct a Phase 2b study to include adolescent patients with the goal to incorporate paediatric patients in their pivotal Phase 3 trials.
PR022 is a proprietary, non-alcohol based, topical gel, 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. The Company has demonstrated that PR022 is associated with a statistically significant therapeutic effect in animal models of atopic dermatitis, including down modulation of key pro-inflammatory cytokines and reduced expression of Th2 cytokines, IL-4, IL-13 and IL-31, as well as TARC and TSLP, which are all linked to the signs and symptoms of the disease. Importantly, these results are delivered without the typical negative effects of commonly used AD immunomodulatory or immunosuppressant drugs, including corticosteroids, suggesting an advantageous safety profile for PR022.
Alex Martin, Chief Executive Officer of Realm Therapeutics, said:
"The filing of the first of our two planned IND submissions in 2017 is an important milestone as Realm progresses its drug development pipeline. We look forward to beginning this Phase 2a study and to reviewing the subsequent data on PR022's efficacy as a potential novel treatment for this debilitating disease. If successful in this and future studies, our PR022 gel will provide a safe and effective alternative to topical steroids and calcineurin inhibitors for children and adults suffering from atopic dermatitis."
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 /Ciara Martin | |
N+1 Singer (Nominated Adviser and Broker) | +44 (0) 20 7496 3000 |
Aubrey Powell / Lauren Kettle |
About Atopic Dermatitis
Atopic dermatitis (AD), a serious form of eczema, is a chronic, relapsing, inflammatory disease characterized by itchy, inflamed skin, which poses a significant burden on patients' quality of life and on the overall health care system. Patients with atopic dermatitis have impaired function of their skin barrier, and this, combined with skin damage as a result of the intense itching and scratching associated with the disease, makes them at risk for secondary infections due to colonization with pathogenic bacteria (particularly Staphylococcus aureus) and changes in the skin microbiome. AD affects up to 20% of children and up to 3% of adults and prevalence numbers continue to increase.
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.