Realm Therapeutics (RLM) is developing a pipeline of novel topical treatments for highly prevalent dermatology indications using its proprietary stabilised hypochlorous acid (HOCl) technology. RLM is investigating the potential already seen in its preclinical studies with topical HOCl formulations to date. They suggest immunomodulatory activity alongside well-documented safety evidence: an encouraging base from which to potentially deliver efficacious and safer alternatives to first line therapies.
RLM confirms that it has met its targeted enrolment completion timeline for its US Phase II study for its lead candidate PR022. This is a topical gel for treating mild-to-moderate Atopic Dermatitis (AD) which is on track to achieve a headline data readout in Q3’18. A total of 122 patients have been recruited into the double-blind, randomised, multi-centre Phase IIa study which included a parallel placebo control group.
The primary endpoint of the study is to evaluate the efficacy and safety of PR022 by using a measurement of the percentage change from baseline using EASI. This is the widely recognised standard investigator assessment of Eczema Area and Severity Index, used to score the severity of AD in clinical trials. Multiple secondary endpoints measured include the percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of 0 - clear or 1-almost clear with a minimum of a 2-grade improvement at Day 29.
Previous preclinical studies with PR022 demonstrated early promise of its immunomodulatory properties and efficacy. AD affects c. 20m people in the US alone and is largely a paediatric condition with few treatment alternatives to first-line topical steroids with side effects that include skin thinning and a comprised immune system with prolonged use. We think that the topical gel stands to gain a share in an expanding treatment segment which has a current estimated Rx value of $4bn (according to the American Academy of Allergy, Asthma & Immunology (AAAAI), provided the early promise is borne out.
RLM is on track to file an Investigational New Drug application (IND) for its second topical dermatology indication for new program RLM023, in Acne Vulgaris in Q418 with a view to a Phase II Proof of Concept study start in Q1’19. AAAAI calculate that there are over 20 million sufferers in the moderate to severe class of Acne Vulgaris with an unmet need for effective treatments with a safer side effect profile than the standard topical retinoids, antibiotics or salicylic acid.
The timeline for the third dermatology indication in Psoriasis, also for PR022 is now firmed up with IND filing planned in Q1’19. Psoriasis is the most prevalent auto-immune disorder in the US with around 7.5m sufferers according to the American Academy of Dermatology, aiming to providing a safer and efficacious treatment alternative to potent first line therapies. The US Psoriasis treatment market is dominated by systemic biologics and the estimated value of which is over $7bn.