SAN DIEGO and COPENHAGEN, Denmark, Oct. 9, 2019 /PRNewswire/ --AFYX Therapeutics, a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced results from a Phase 1 clinical proof of concept study evaluating the use of the Rivelin® bio-adhesive patch in patients with vulvar lichen sclerosus (VLS), a painful genital skin condition that affects up to 3% of post-menopausal women. All twelve patients in the study reported the successful self-application of the Rivelin patch to VLS lesions with a mean adhesion time of more than nine hours. No safety issues were reported and the patch was well tolerated. AFYX Therapeutics will proceed with the next phase of development, testing the ability of the Rivelin patch to not only adhere to, but also deliver a therapeutic to treat VLS lesions. Findings were presented at the 2019 European Academy of Dermatology and Venereology (EADV) Congress taking place October 9-13, 2019 in Madrid, Spain.
"We achieved the primary goal of demonstrating easy self-application and effective adhesion of the Rivelin patch in patients with VLS," said Nishan de Silva, M.D., chief executive officer of AFYX Therapeutics. "As we've already shown in early clinical studies of the Rivelin program in oral lichen planus, the Rivelin patch has the potential to adhere to and consistently deliver medication to lesions on mucosal tissue. We believe this intervention could benefit many patients with VLS where topical ointments and creams are ineffective."
The study assessed the adhesive effectiveness of patches in patients with vulvar lichen sclerosus. Patient-reported outcomes of women ages 24 to 61 showed that all patients were able to easily apply the patch and sustained adhesion was achieved, with mean adhesion time of 9.5 hours on day 1 and 10.0 hours on day 2. Clinical outcomes assessments in the 12-patient study also showed that VLS symptoms of discomfort, pain, itching and burning were lower 2 hours after application. Redness, erosion and oedema also decreased for nearly all patients.
About Vulvar Lichen Sclerosus Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin disease that affects the mucosal surfaces of the anogenital area in women. VLS may appear as fissures, atrophy, edema, erosion, and/or thickened hyperkeratotic plaques in the genital area that may cause localized pain, as well as pain in urination and sex. Left untreated, patients with VLS have increased risk of developing squamous cell carcinoma, the second most common type of skin cancer. No U.S. Food and Drug Administration (FDA) approved treatment exists, with off-label steroids, often in the form of creams or ointments, as standard of care.
About Rivelin® Patch Platform AFYX Therapeutics has developed the Rivelin patch, a breakthrough therapy for the treatment of mucosal diseases. Rivelin is designed to deliver a pharmaceutical drug uni-directionally to a mucosal surface using an occlusive, bio-adhesive and bio-degradable patch, with a long adhesion time and a high flexibility, conforming to the mucosal surface. The first Rivelin patch product candidate seeks to treat the inflammatory disease oral lichen planus (OLP) through direct delivery of the drug clobetasol propionate.
About AFYX Therapeutics AFYX Therapeutics is a clinical stage biopharmaceutical company focused on innovative approaches to treat mucosal diseases. AFYX Therapeutics' lead product candidate, Rivelin®-CLO patch, is currently in Phase 2b clinical development for the treatment of oral lichen planus (OLP) a chronic inflammatory disease that affects 1% of the population. 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.