Realm Therapeutics (RLM) reports that it is making excellent progress advancing its proprietary therapeutic pipeline for inflammatory disease, with a cash reach to cover its Phase II programs in the first three indications. RLM’s Phase II study of PR013 in Allergic Conjunctivitis (AC) is progressing ahead of schedule with the expected top line readout shifting into Q118 (from Q2). As a reminder, RLM initiated the double blind, randomised, placebo controlled efficacy study of its topical solution using a modified Conjunctival Allergen Challenge Model Ora-CAC® in December measuring primary endpoints, ocular redness and itch.
If the trial data achieves a certain high level of clinical efficacy, this could mean that just one additional pivotal study will be needed to support an NDA filing of PR013. The commercial potential of PR013, provided data support efficacy and safety profile, is as an alternative to topical steroids which have serious side effects, for nonresponders to standard dual-acting antihistamines, a pool of c 3.7m people in the US according to ORA Clinical.
RLM’s Phase IIa study of topical gel PR022 in mild to moderate Atopic Dermatitis (AD) is also progressing to plan, with data due in Q318. The primary endpoint of the doubleblind, randomised, multi-centre, placebo controlled study is the evaluation of the efficacy and safety of PR022 using percentage change from baseline assessing Eczema Area and Severity Index (EASI).
Previous studies demonstrated the early promise of PR022 and 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 significant share in a growing market segment which has an estimated Rx value of $4bn (source: the American Academy of Allergy, Asthma & Immunology - AAAAI). Again that is assuming good safety and efficacy profile seen to date is borne out in clinical trials.
RLM has also firmed up the timeline for its Investigational New Drug application for RLM023 in Acne Vulgaris, expected in Q418. This is expected to lead to the direct entry of RLM023 into a Phase II Proof of Concept study shortly afterwards, providing further validation of the versatility of RLM’s Hypochlorous Acid (HOCl) technology. 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.
RLM’s December 2017 year-end cash position of $33.9m is in line with our estimate and enough to cover the ongoing Phase II trials in AC and AD, and a Phase II Proof of Concept study for RLM023, taking the cash reach on our forecasts into Q319.