RLM15 Aug 2018 23:02
Novel Therapeutics for Immune-Mediated Diseases
Utilizing our proprietary technology, Realm is developing novel prescription therapeutics with the potential to be first in class immunomodulatory treatments. Our initial target indications are in dermatology: Atopic Dermatitis, Acne Vulgaris and Psoriasis. We have demonstrated that our technology has broad-spectrum immunomodulatory properties and believe it has potential application in many other immune-mediated diseases with significant unmet medical needs.
PR022 for Atopic Dermatitis
PR022 is a proprietary, non-alcohol based, topical gel formulation of high concentration of hypochlorous acid (HOCl), offering a differentiated mechanism of action for the treatment of Atopic Dermatitis.
In pre‑clinical models of Atopic Dermatitis, the Company has demonstrated that PR022 is associated with a statistically significant therapeutic effect, including down modulation of key cytokines IL-4, IL-13 and TARC, as well as cytokines associated with itch, including IL-31 and TSLP. Importantly, these results were demonstrated without the typical immunosuppressive impact of steroids, the current standard of care, suggesting an advantageous safety profile for PR022.
PR022 is currently being studied in a Phase 2 clinical trial. The study is being conducted in the United States and is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group trial to assess the safety and efficacy of PR022 topical gel in approximately 120 adults with mild-to-moderate Atopic Dermatitis. Based on outcomes of this study, the Company intends to conduct a Phase 2b study to include adolescent patients.
Atopic Dermatitis, a serious form of eczema, is a chronic, relapsing, inflammatory disease characterized by itchy, inflamed skin, which poses a significant burden on patients’ quality of life and on the overall health care system. It is most commonly first diagnosed in childhood. Patients with Atopic Dermatitis have impaired function of their skin barrier, which, combined with skin damage as a result of the intense itching and scratching associated with the disease, puts them at risk for secondary infections due to colonization with pathogenic bacteria (particularly Staphylococcus aureus) and changes in the skin microbiome.
Atopic Dermatitis affects an estimated 20 million people in the U.S., including up to 20% of children and up to 3% of adults, and prevalence continues to increase. The Company believes that peak year sales for PR022 could potentially reach $1.0 billion in the U.S. alone, based on market analysis.
RLM023 for Acne
RLM023 is a topical formulation of HOCl that is optimized for Acne. We believe that an HOCl based formulation may offer a promising treatment for Acne due to its anti-inflammatory and anti-microbial properties. In in vitro and in vivo pre-clinical studies, HOCl demonstrated a reduction in the expression of pro-inflammatory cytokines such as TNF-α, IL 1β, IF
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