Oral patch improves ulcers in phase 2b study

A biodegradable oral adhesive patch demonstrated significant improvement in patients with oral lichen planus (OLP), according to AFYX Therapeutics, which reported the phase 2b trial results April 22. The Rivelin Clobetasol patch (Revelin-CLO) is designed for local delivery of clobetasol to treat symptomatic OLP lesions. A novel technology allows it to adhere to mucosal surfaces, such as the mouth, to provide continuous and targeted therapy where topical and other treatment modalities have proven inadequate, the company says.

“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 in the press release.

The study enrolled 138 adult patients who were diagnosed with oral lichen planus and who had at least one visible and measurable symptomatic ulcerative lesion, the company said. Patients were randomized to one of three active dose arms (Rivelin-CLO 1 μg/patch; Rivelin-CLO 5 μg/patch; Rivelin-CLO 20 μg/patch) or a placebo arm (Rivelin placebo patch). All patients received twice-daily treatment with weekly evaluations for four weeks. The 20μg dose of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area and continued to show improvement through the end of four weeks.

According to the company, secondary endpoints focused on capturing patient symptomatic improvement and demonstrated statistical significance, further validating the clinical benefit observed in these patients. Patients reported the treatment was easy to use and there were no serious adverse events observed.

“This is very encouraging data for a disease that has been overlooked, and I look forward to further evaluating Rivelin in phase 3 studies,” said Principal Investigator Michael Brennan, DDS MHS, professor and chair, department of oral medicine at Atrium Health’s Carolinas Medical Center, Charlotte, N.C.

AFYX Therapeutics is a clinical stage biopharmaceutical company developing treatments for mucosal diseases. OLP is a chronic, inflammatory disease characterized by symptomatic lesions and ulcers in the mouth. It affects about 6 million patients in the United States and Europe, and there are no currently approved treatments. Investigators view Rivelin-CLO as a potential solution to address this unmet medical need, the company says.

“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,” Dr. de Silva noted in the press release.