SAN DIEGO & COPENHAGEN, Denmark--(BUSINESS WIRE)--AFYX Therapeutics (“AFYX”), a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced that a study of the Rivelin® Clobetasol patch (“Rivelin-CLO”), a novel adhesive patch technology designed to deliver a therapeutic agent to wet tissue surfaces, was featured in the March issue of The European Journal of Oral Sciences. This is the first study to show the successful transmucosal delivery of a corticosteroid using electrospun patch technology and confirmed that the drug delivered retained its anti-inflammatory activity.
Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat symptomatic Oral Lichen Planus (OLP) lesions. The therapeutic patch utilizes electrospinning technology that is 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 prolonged, inflammatory disease defined by lesions and ulcers in the mouth. It is estimated to affect over one percent of the population within the United States and Europe, which accounts for nearly six million patients.
“Rivelin-CLO has the power to deliver targeted, localized quantities of clobetasol to diseased tissue in the mouth for patients with OLP, a condition for which there are no approved therapies,” said Nishan de Silva, M.D., CEO of AFYX Therapeutics. “This new mucoadhesive patch technology holds great promise for the treatment of patients with mucosal diseases. These are conditions which may benefit from treatments such as corticosteroids, anesthetics and analgesics, all of which require specific, controlled delivery directly to wet tissue.”
Recently, the company completed a phase 2 trial of Rivelin-CLO in the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients. The patients who were administered a 20μg dose of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area and continued to show improvement through the end of 4 weeks.
About Rivelin Patch Technology
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.
About AFYX Therapeutics
AFYX Therapeutics is a clinical stage biopharmaceutical company focused on innovative approaches to treat mucosal diseases. AFYX’s lead product candidate, Rivelin-CLO patch, met its primary endpoint and multiple secondary endpoints in a Phase 2b clinical study for the treatment of oral lichen planus, a chronic inflammatory disease that affects over 1 percent of the population in the U.S. and Europe. The Rivelin patch technology is able to adhere to mucosal surfaces, such as the mouth, to provide continuous and targeted therapeutic delivery for diseases where topical and other treatment modalities have proven inadequate. Investors include Sofinnova Ventures, Lundbeckfonden Emerge, Novo Seeds and Welfare Tech Invest. For additional information, please visit www.afyxtx.com.