SAN DIEGO & COPENHAGEN--(BUSINESS WIRE)--AFYX Therapeutics (“AFYX”), a clinical-stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced Phase 2 clinical efficacy and safety data of Rivelin® Clobetasol (“Rivelin-CLO”), a novel mucoadhesive patch designed to deliver clobetasol to lesions on wet tissue surfaces for the treatment of oral lichen planus (OLP). In this Phase 2 study investigating Rivelin-CLO across more than 20 clinical trial sites, a 20-µg dose resulted in a clinically significant reduction in OLP ulcer size, improvements in symptoms and quality of life, and a favorable safety profile compared to placebo – demonstrating its potential to address a significant unmet need in OLP. These data were presented during an oral session at the 2021 American Academy of Oral Medicine (AAOM) Virtual Annual Conference.
“OLP is a chronic inflammatory condition causing agonizing mouth ulcers– and despite the continual pain and poor quality of life it inflicts on six million people in the U.S. and Europe, patients are left with no approved treatment options and rely on ineffective topical medicines,” said Michael Brennan, DDS, MHS, FDS RCSEd, professor and chair, Department of Oral Medicine at Atrium Health Carolinas Medical Center, and presenter of the study. “These data show the promise of a novel mucoadhesive clobetasol patch approach such as Rivelin-CLO to effectively treating these conditions that have remained overlooked for far too long.”
This was the first and largest global, randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in patients with OLP. In the study, 138 adults with symptomatic OLP and ≥1 measurable ulcers were randomized to 1, 5, 20 µg/patch doses or placebo in 1:1:1:1 ratio. Rivelin-CLO was applied daily for four weeks to visible and measurable symptomatic OLP lesions, and the study included a two-week follow-up after the end-of-dosing period. Patches were universally reported as easy to apply, remove, well tolerated and associated with high compliance. Most adverse events deemed to be related to treatment were mild, localized and did not result in study discontinuation.
Statistically significant improvement in ulcer size at 20-μg dose
The primary endpoint was the change in ulcer size versus baseline. The 20-μg treatment resulted in significant reduction in total ulcer area (‑45.0 mm2; p<0.05), symptom severity score (-2.967; p<0.001; 28-point scale), clinician’s severity assessment (-4.453; p<0.05; 106-point scale), and oral-mucosal disease-specific QoL (‑9.022; p<0.05; 104-point scale). The 1 and 5 ug/patch treatments showed positive impact but did not broadly reach significance.
“Our Rivelin patch technology is designed to bring unidirectional, targeted drug delivery to one of the most difficult areas of medicine to treat: mucosal diseases,” said Nishan de Silva, M.D., CEO of AFYX Therapeutics. “With these clinically significant Phase 2 data in hand and a recommended go-forward dosage of Rivelin-CLO, there is the potential to finally deliver a treatment option that can benefit the OLP patient community. We look forward to continuing to advance the development of Rivelin-CLO.”
A copy of the presentation, titled “Efficacy and Safety of a Novel Mucoadhesive Clobetasol Patch for Treatment of Oral Lichen Planus,” is available on AFYX’s website at https://afyxtx.com/#publications.
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.