MALVERN, Pa., Feb. 15, 2018 /PRNewswire/ -- Realm Therapeutics plc (AIM:RLM), a clinical stage biopharmaceutical company focused on developing novel therapeutics in immune-mediated diseases, today provided a clinical and business update.
"In 2017, we set and met transformational goals, turning Realm into a clinical stage company focused on novel therapeutics for immune-mediated diseases," said Alex Martin, Chief Executive Officer of Realm.
"The Company submitted INDs for our two lead candidates, PR022 for Atopic Dermatitis and PR013 for Allergic Conjunctivitis, which the FDA allowed to proceed directly into Phase 2 studies, and both trials were initiated in the fourth quarter of 2017. We are pleased to be ahead of schedule in our PR013 study, with top-line results expected by the end of the first quarter and we are on schedule to release top-line PR022 study results by the end of the third quarter. We are also delighted to confirm our progress in our Acne program as we plan to submit an IND in the fourth quarter and initiate a clinical study shortly thereafter. With current resources and on current plans, Realm is well-positioned to execute on these clinical programs and to explore other potential disease applications for our proprietary immunomodulatory technology through pre-clinical studies."
Clinical Development Highlights
- The Company initiated a Phase 2 study of PR013 in Allergic Conjunctivitis (AC) in December 2017. The study is a multi-center, double-blind, randomized evaluation of the effectiveness of multiple doses of PR013 topical ophthalmic solutions compared to vehicle for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®) in approximately 90 patients. The Ora-CAC® model has been the accepted standard for the successful development of novel treatments for AC in the U.S. for the past three decades.
- The Phase 2 AC study is ahead of schedule with top-line results expected by the end of Q1, rather than in Q2, as previously indicated.
- In late 2017, Realm initiated a Phase 2 study of PR022 in Atopic Dermatitis (AD). The study is a randomized, double-blind, vehicle-controlled, multi-center, parallel-group study assessing the safety and efficacy of multiple doses of PR022 topical gel in approximately 120 adult patients with mild-to-moderate atopic dermatitis. Multiple endpoints are being explored, including EASI1 and IGA2, as well as additional assessments of pruritus and quality of life.
- The AD Phase 2 study is progressing to plan with top-line results expected by the end of Q3.
- The Company plans to file an Investigation New Drug Application (IND) for Acne Vulgaris in Q4 and, pending FDA allowance, commence a Phase 2 proof of concept study shortly thereafter.
- Cash, cash equivalents and short-term investments were $33.9 million at December 31, 2017 (December 31, 2016: $21.4 million), reflecting the net proceeds of the $26 million (gross) October 2017 financing.
- The Company expects to announce its audited final results for the year ended December 31, 2017 in early Q2 and a further announcement on timing will be made in due course.
1Eczema Area and Severity Index (EASI) is an investigator-assessed tool used to measure the extent (area) and severity of atopic eczema.
2 Investigator Global Assessment (IGA), is an investigator-assessed instrument measuring severity of atopic dermatitis on a 5 grade scale.
About Realm Therapeutics
Realm Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics that target the intersection between innate and adaptive immunity, to influence immune signaling and to change the course of immune-mediated diseases in adults and children. Realm's lead drug development programs utilize the Company's proprietary immunomodulatory technology for the treatment of Allergic Conjunctivitis (PR013) and Atopic Dermatitis (PR022) and Realm is exploring its efficacy in Acne and additional Dermatology and Ophthalmology indications as well as other disease 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. 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.
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
+1 212 600 1902
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
SOURCE Realm Therapeutics