Realm completes enrolment in Phase 2 atopic dermatitis treatment study

Clinical-stage biopharmaceutical company Realm Therapeutics has completed enrollment in its Phase 2 study of PR022 - its topical IL-4 / IL-13 inhibitor for the treatment of atopic dermatitis - it announced on Thursday.

The AIM-traded firm said the trial was being conducted in the United States, and it continued to expect to report top line results in the third quarter of this year.

“This Phase 2 study is designed to demonstrate that PR022, our proprietary topical gel formulation of high concentration hypochlorous acid, has the potential to be a clinically meaningful treatment alternative for patients suffering from atopic dermatitis," said Realm CEO Alex Martin.

“In pre-clinical models of atopic dermatitis, PR022 has shown immunomodulatory effects, without the same immunosuppressive side effects often associated with steroids, which are the current standard of care.

“This data suggests a potential clinical advantage for PR022 that could be especially beneficial for the large pediatric segment of the atopic dermatitis patient population.”

Realm said the Phase 2 study was a randomised, double-blind, vehicle-controlled, multicentre, parallel-group study assessing the safety and efficacy of multiple doses of PR022 in 122 adult patients with mild-to-moderate atopic dermatitis.

Multiple endpoints were being explored, including eczema area and severity index (EASI) - an investigator-assessed tool used to measure the extent and severity of atopic eczema - and Investigator Global Assessment (IGA) - an investigator-assessed instrument measuring severity of atopic dermatitis on a five-grade scale; as well as additional assessments of pruritus and quality of life.

The company also announced that the United States Patent and Trademark Office had issued a notice of allowance for a new patent that expanded Realm's intellectual property portfolio related to its proprietary immunomodulatory technology.

It said US Patent Application 15/184,207, entitled ‘Stabilized Hypohalous Acid Solutions,’ provided further coverage for composition of matter for the stabilised formulation of HOCl, for Realm's gel formulations PR022 and RLM023, as well as methods of treatment with those formulations.

The patent included specific claims for treating atopic dermatitis, psoriasis and acne.

“This additional patent allowance expands Realm's intellectual property protection for formulations based on our proprietary platform technology,” Martin added.

“We believe our technology has broad-spectrum immunomodulatory effects, with potential applications in atopic dermatitis, acne, psoriasis and potentially other immune-mediated diseases.

“As previously announced, we plan to file two Initial New Drug applications - one for RLM023 in acne, expected by the end of this year, and another for PR022 in psoriasis expected in the first quarter of 2019.”