AFYX Therapeutics Achieves Primary Endpoint in Phase 2b Trial of Rivelin-CLO in Patients with Oral Lichen Planus
SAN DIEGO and COPENHAGEN, April 22, 2020 /PRNewswire/ -- AFYX Therapeutics ("AFYX"), a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced that its Rivelin® Clobetasol patch ("Rivelin-CLO") met the primary and multiple secondary endpoints in a Phase 2b study in patients with oral lichen planus ("OLP"). In the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients, the 20μg dose (Phase 3 recommended dose) of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of 4 weeks. Secondary endpoints focused on capturing patient symptomatic improvement also demonstrated statistical significance, further validating the clinical benefit observed in these patients. No serious adverse events were observed and patients reported overall ease of use and patch adherence to the oral cavity for an average of 90 minutes.
"We are excited by the results of this Phase 2b study of Rivelin-CLO, which clearly demonstrated first-of-its kind therapeutic benefit for patients with OLP, a condition for which no approved therapies exist," said Nishan de Silva, M.D., CEO of AFYX Therapeutics. "Investigators we have been working with have expressed challenges with existing treatment options – topical treatments, ointments and mouth rinses that don't provide adequate results – and view Rivelin-CLO as an important potential solution for addressing these unmet medical needs. Based on the strength of these results, we plan to move 20μg Rivelin-CLO into Phase 3 clinical studies. We look forward to sharing more detailed results at a future medical/scientific meeting."
Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat symptomatic OLP lesions. It uses a novel electrospinning technology to create a unique patch capable of adhering to the oral cavity for an average of 90 minutes, and other wet tissue surfaces for approximately 9.5 hours, while delivering a steady therapeutic dose to the lesion. OLP is a chronic, inflammatory disease characterized by symptomatic lesions and ulcers in the mouth, and is estimated to affect over 1 percent of the population in the United States and Europe, or over 6 million patients combined. There are no approved treatments for OLP.
"Rivelin-CLO adhered to wet tissue inside the mouth of patients with OLP, delivered a steady dose of clobetasol that led to a significant reduction in wound size, and patients were able to easily adhere to the treatment regimen," said Principal Investigator Michael Brennan, DDS MHS, Professor and Chair, Department of Oral Medicine at Atrium Health's Carolinas Medical Center, Charlotte, NC. "This is very encouraging data for a disease that has been overlooked, and I look forward to further evaluating Rivelin in Phase 3 studies."
The Phase 2b trial enrolled 138 adult patients diagnosed with OLP and who had at least one visible and measurable symptomatic ulcerative lesion. The study, conducted in Europe and North America, was 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 placebo patch). Patients were treated twice daily and evaluated on a weekly basis for 28 days of treatment. 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 wet tissue surfaces. 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 nonaffected parts. Rivelin may significantly improve the treatment paradigm for OLP and other inflammatory mucosal diseases, which today are largely addressed with unapproved or inconvenient ointments, inhalers or mouthwashes.
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