Afyx Therapeutics reported positive results from a phase 2b trial of Rivelin Clobetasol patch (Rivelin-CLO) for the treatment of oral lichen planus (OLP). The trial met the primary and multiple secondary endpoints. Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat symptomatic OLP lesions.
The Phase 2b trial was a randomized, double-blind and placebo-controlled design and enrolled 138 adult patients diagnosed with OLP and who had at least one visible and measurable symptomatic ulcerative lesion. The study consisted of 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.
The 20μg 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. 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. Detailed results will be presented a medical or scientific meeting.
Based on the phase 2b results, Afyx plans to move 20μg Rivelin-CLO into Phase 3 clinical studies.
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.
About oral lichen planus (OLP)
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.