Realm Therapeutics plc, a clinical stage biopharmaceutical company focused on developing novel therapeutics in immune-mediated diseases, has 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, CEO 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 US 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.