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Realm Therapeutics plc (RLM), a clinical stage bio-pharmaceutical company focused on developing novel therapeutics in immune-related diseases based on its proprietary hypochlorous acid (HOCl) technology, has reported preliminary top-line data from its Phase II trial of PR022 in Atopic Dermatitis, in tandem with H1’18 financial results.
Realm Therapeutics
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.
Realm Therapeutics (RLM) is developing a pipeline of novel topical treatments principally to treat highly prevalent dermatology indications using its proprietary hypochlorous acid (HOCl) technology, which has shown immunomodulatory properties coupled with a potentially favourable safety profile. FY’17 highlights included entry of lead program PR022 a topical gel to treat Atopic Dermatitis into FDA Phase II study due to provide headline data in Q3’18.
Realm Therapeutics (RLM) reports that top line results from its Phase II study of PR013 in Allergic Conjunctivitis (AC) failed to show efficacy and that consequently it has decided to cease further development of the topical (HOCl) hypochlorous acid-based ocular solution for AC application. The Company is continuing to prioritise the ongoing development of its most advanced dermatology programs in Atopic Dermatitis (AD) and Acne Vulgaris. There are distinct inflammatory mechanisms at play in AC as compared to in the dermatology indications. Lead product PR022 in AD is currently in Phase II studies, while RLM plans to file an Investigational New Drug application (IND) for a new program RLM023, in Acne Vulgaris in early Q418.
Oxford BioMedica (OXB LN) £20.5m raised to fund bioprocessing expansion | Raven Russia Ltd (RUS LN) Good results – high yields | Realm Therapeutics (RLM LN) Disappointing Allergic Conjunctivitis data, Atopic Dermatitis on track | Vectura Group (VEC LN) Pathway clarified for VR315 US, clinical endpoint study required
RLM OXB VEC RAV
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.
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 Phase II trial start for PR013 in Allergic Conjunctivitis follows the recent (5th Dec) start of Phase II trials for PR022 in Atopic Dermatitis, and represents an expected but nevertheless positive development for Realm Therapeutics. In preclinical models, PR013 has demonstrated a significant reduction in itch and a similar reduction in redness vs. high-dose topical steroids. We look forward to top-line results in Q2 2018 and reiterate our positive stance on Realm Therapeutics.
The Phase II trial start for PR022 in Atopic Dermatitis (AD) is an expected but nevertheless very positive development for Realm Therapeutics. In our view, AD represents a significant commercial opportunity, as highlighted by the recent approvals and current sales projections for Pfizer’s EUCRISA® and Sanofi/Regeneron’s Dupixent® ($0.7bn and $3.5bn respectively by 2021). We look forward to top-line results in Q3 2018 with anticipation, and reiterate our highly positive stance on Realm Therapeutics.
The proposed Placing announced this morning, to raise £19.3m, represents an important inflection point for Realm. Both of the company’s lead programmes (PR022 in atopic dermatitis and PR013 in allergic conjunctivitis) are due to enter Phase II by the end of 2017, with data expected in mid-2018. Although the initial Phase II trials are fully funded through to completion by existing cash resources ($15.56m at period-end), the additional capital from the Placing will provide greater flexibility following next year’s read-outs, including a potential partnering and/or further development of one or more programmes. In addition, it will fund studies of the potential utility of topical hypochlorous acid in additional large indications such as acne, psoriasis and dry eye. In our view, Realm following the capital raise is exceptionally well placed to execute its commercial strategy: we reiterate our highly positive stance.
Realm Therapeutics (RLM) reports alongside FY16 financial results that its clinical pipeline is advancing to plan. RLM also confirms that both of its lead candidates - PR022, a novel high concentration formulation of hypochlorous acid (HOCl) to treat Atopic Dermatitis (AD) and PR013 to treat Allergic Conjunctivitis (AC) - will move into Phase II studies in 2017. Consequently, top line data readouts for both candidates is anticipated during H118. The novel topical treatments aim to provide efficacious and safer alternatives to standard treatments in both indications providing significant commercial potential. The year end 2016 cash position of $21m provides funding to cover the first Phase II study in each indication.
Realm Therapeutics (RLM) is advancing its pipeline to plan having received FDA approval to take its lead candidate PR022 a novel high concentration formulation of hypochlorous acid (HOCl), into Phase II studies in atopic dermatitis (AD). With a strong body of safety evidence on the active of PR022 at hand, RLM has effectively bypassed the Phase I stage. With a high unmet need for safer alternatives to standard topical corticosteroids in mild-tomoderate AD, RLM targets, alongside recently approved Eucrisa (Pfizer), for a share of the strongly steroid-averse patient pool, which has a current Rx value of c $4bn. RLM also reports that further pre-clinical data to be presented at key dermatology conference this week reinforce the evidence of the diseasemodifying activity of PR022.
The disposal for Supermarket Retail for $13.5m is in line with the company’s stated strategy following its recent strategic review, the results of which were announced in Feb 2016. The main use of proceeds will be to progress development of immuno-modulatory therapeutics in dermatology and ophthalmology, leveraging the significant IP and know-how accumulated by the company in relation to the use and formulations of hypochlorous acid. The first two IND filings are planned for Q1 2017. We view today’s disposal as an exciting and significant step towards PuriCore delivering on its strategic objectives, and look forward to more data from the company’s development programmes in due course.
PuriCore has announced it has had a successful first pre-IND meeting with the FDA and is on track to submit an IND application in Q1 2017 for its lead product, a topical treatment for Atopic Dermatitis. Puricore remains at an interesting juncture in its development as it transitions to a fully fledged drug development company based on leveraging its proprietary immunomodulatory technology to develop novel, topical treatments for inflammatory diseases.
Puricore remains at an interesting juncture in its development as it transitions to a fully fledged drug development company based on leveraging its proprietary immunomodulatory technology to develop novel, topical treatments for inflammatory diseases. The Supermarket Retail division, now deemed non-core, delivered a strong revenue performance but still requires investment support. As such options are being considered that could drive further growth and generate shareholder value.
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