Realm Therapeutics (RLM) has initiated US Phase II studies in Atopic Dermatitis (AD) and in Allergic Conjunctivitis (AC), for two novel therapies based on its proprietary Hypochlorous acid technology, which offer promise of good safety coupled with disease-modifying potential in prevalent inflammatory disease, and where there is significant unmet need for alternatives to standard topical steroids.
The Company has also expanded the preclinical pipeline to cover three potential new candidates in related ocular and dermatology markets including in the moderate-tosevere acne prescription market, a potential pool of up to 20 million sufferers according to the American Academy of Dermatology (AAD).
RLM has initiated a double-blind, placebo controlled Phase IIa study with PR022 a topical gel in mild-to-moderate Atopic Dermatitis. Previous studies demonstrated early promise of its immunomodulatory properties and efficacy alongside good tolerability. Given that there are few non-steroid topical treatment alternatives, we think that PR022 stands to gain a share in this expanding segment which has a current estimated Rx value of $4bn according to the American Academy of Allergy, Asthma & Immunology (AAAAI), provided the good safety and efficacy profile seen to date is borne out in clinical trials
The Company has also dosed the first patient in a Phase IIb study with PR013 in Allergic Conjunctivitis (AC). The study will be conducted using the well-established OraCAC® model. An estimated 3.7 million AC sufferers in the US are reported to fail on first line treatments, but have few options other than topical steroids which have serious long-term side effects.
RLM’s expanded pipeline covers new preclinical indications which present natural applications for the immunomodulatory potential of HOCl and where there are common underlying mechanisms at play: including potentially in Dry Eye and Psoriasis. The most advanced is RLM023 in Acne Vulgaris. RLM plans to file an Investigational New Drug application during 2018 which could potentially lead to direct entry into Phase II study.
RLM ended the six-month period to June 2017 with a net cash position of $15.6m and we project that the subsequent over-subscribed $26m gross placing in October provides a cash runway into Q319 to cover current Phase II studies for lead programs plus a potential Phase IIa study in acne vulgaris.