Dermtreat today announced treatment of the first patient in a Phase 2b clinical trial of Rivelin® Clobetasol patch for oral lichen planus. Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat lesions and ulcers in the mouth caused by OLP.
| Dermtreat, a clinical-stage biopharmaceutical company focused on mucosal diseases, today announced treatment of the first patient in a Phase 2b clinical trial of Rivelin® Clobetasol patch (Rivelin®-CLO) for oral lichen planus (OLP). Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat lesions and ulcers in the mouth caused by OLP. OLP is a chronic, inflammatory disease characterized by symptomatic lesions and ulcers in the mouth. It’s estimated to affect 1 percent of the population, or over 6 million patients in the U.S. and EU. There is no approved topical treatment for OLP. “Oral lichen planus causes pain and disrupts actions that are essential to basic quality of life such as talking, eating, swallowing and maintaining good dental hygiene, yet it remains poorly served by off-label topical treatments,” said Nishan de Silva, M.D., chief executive officer of Dermtreat. “The Rivelin patch is the first of its kind designed to enable targeted delivery of clobetasol to lesions in the mouth, adhering to mucosal tissue for up to two hours, and acting as a barrier to irritation from food and other consumables. Based on the high unmet medical need and the interest we’ve seen from leading physicians and specialists in the field, we anticipate efficient study enrollment and expect results in the first half of 2019.” The Phase 2b trial will enroll approximately 240 adult patients clinically diagnosed with OLP and who have at least one visible and measurable symptomatic ulcerative lesion. Conducted at up to 20 sites in Europe and North America, the study is a randomized, double-blind and placebo-controlled clinical trial with three active dose arms (Rivelin-CLO 1 μg/patch; Rivelin-CLO 5 μg/patch; Rivelin-CLO 20 μg/patch) and one placebo arm (Rivelin plain patch). Patients will be treated twice daily and evaluated on a weekly basis for 28 days of treatment. The primary objective of the trial is to demonstrate the efficacy of three different doses of Rivelin-CLO patches in treating OLP lesions over four weeks of treatment assessed by change in ulcer area. Secondary objectives will evaluate change in lesion area and symptom scores. More information is available at www.clinicaltrials.gov (Identifier #NCT03592342). Rivelin, is a muco-adhesive two layered patch that delivers a pharmaceutical product (such as clobetasol) directly to patients’ mucosal surface of the oral cavity. Rivelin utilizes a unique patch technology that adheres to mucosal surfaces for extended periods, facilitating uni-directional delivery of a pharmaceutical agent to the target site of action impacting disease progression, while limiting delivery to surrounding areas. This should enable higher efficacy, lower dosing and less toxicity to non-affected parts of the oral cavity. Rivelin may significantly improve the treatment paradigm for oral lichen planus and other inflammatory oral diseases, which today are largely addressed with unapproved or inconvenient ointments, inhalers or mouthwashes. Preclinical studies of the Rivelin patch for oral mucosal diseases were recently published in the journal Biomaterials. About Oral Lichen Planus About Rivelin® Patch Platform About Dermtreat View original content:http://www.prnewswire.com/news-releases/dermtreat-announces-first-patient-dosed-in-phase-2b-clinical-trial-of-rivelin-clobetasol-for-oral-lichen-planus-300684474.html SOURCE Dermtreat |
