AFYX Therapeutics Announces Completion of Enrollment in Phase 1 Clinical Trial of the Rivelin Patch in Patients with Vulvar Lichen Sclerosus
SAN DIEGO and COPENHAGEN, Denmark, Dec. 4, 2018
SAN DIEGO and COPENHAGEN, Denmark, Dec. 4, 2018 /PRNewswire/ -- AFYX Therapeutics, a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced that it has completed enrollment in its Phase 1 clinical trial of the Rivelin patch in patients with vulvar lichen sclerosus (VLS). The study enrolled 12 patients to evaluate the adhesion time, compliance and general feasibility of a plain Rivelin patch (no active drug) in patients with VLS. Results from the study are expected in the first quarter of 2019.
"Treatment options for mucosal diseases such as vulvar lichen sclerosus are largely suboptimal at delivering appropriate therapy to patients because topical treatments don't stay at the site of disease or patches don't stick to wet tissue," said Nishan de Silva, M.D., chief executive officer of AFYX Therapeutics. "AFYX has developed the Rivelin patch, the first self-adhesive drug patch designed to deliver uniform doses of pharmaceuticals to mucosal surfaces."
Vulvar lichen sclerosus is a chronic inflammatory condition in the vulva, groin, and perianal region that is most common in postmenopausal women. Symptoms of VLS may include itching (pruritus), discomfort or pain, smooth white spots, blotchy and wrinkled patches of skin, easy bruising or tearing, and, in severe cases, bleeding, blistering, or ulcerated lesions. Patients with lichen sclerosis have an increased risk of developing a cancer known as squamous cell carcinoma, making early detection and treatment especially important. There are currently no approved medical treatment for VLS, and standard of care today relies on off-label steroids, often in the form of creams or ointments that can easily rub off on clothing and do not remain securely at the lesion site.
Objectives of the Phase 1 open-label single-center study are to evaluate adhesion time on relevant regions of the body and to understand tolerability and sensation of the Rivelin plain patch. Based on the outcome of the study, further work is planned to optimize the patch in terms of size, shape, active drug substance and adhesion profile.
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 is currently in Phase 2b clinical development for the treatment of the inflammatory disease oral lichen planus (OLP) through direct delivery of the drug clobetasol propionate.
Rivelin patches are developed using AFYX Therapeutics' electrospinning process, in which ultra-fine fibers are created in the form of a mesh-like lattice capable of holding pharmaceutical substances. This results in a biodegradable dual-layer material with a very high surface area, which when used with adhesive polymers, allows the patch to adhere to wet surface for sustained periods of time. Once adhered, the moisture from mucosal tissue interacts with the fibers to release drug substance from the patch. A second layer on the back of the patch is impenetrable [to moisture], preventing drug loss and driving drug penetration into the mucosal tissue. The result is a flexible, biocompatible, mucoadhesive patch that releases a therapeutic over a significant period of adhesion. This should enable higher efficacy, lower dosing and less toxicity to non-affected parts of the treatment site.
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.
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SOURCE AFYX Therapeutics