SAN DIEGO and COPENHAGEN, Denmark, Sept. 27, 2018 /PRNewswire/ -- AFYX Therapeutics (formerly known as Dermtreat), a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced that clinical and preclinical data on the safety, effectiveness and manufacture of the Rivelin^® patch, the first and only muco-adhesive drug delivery system, were presented at the 14^th Biennial Congress of European Association of Oral Medicine (EAOM) taking place in Gothenburg, Sweden. Three poster presentations feature: Phase 1b results demonstrating that the Rivelin patch adheres to lesions in the oral cavity of patients; preclinical data demonstrating targeted and sustained therapeutic delivery of clobetasol; and the feasibility of using an electrospinning manufacturing method to develop the Rivelin muco-adhesive drug delivery system. Patients are currently enrolling in a Phase 2b study of Rivelin-Clobetasol for the treatment of oral lichen planus, a chronic inflammatory disease causing painful lesions in the mouth and affecting more than 1% of the population in the US and Europe.

"There are currently no approved therapies for many mucosal diseases such as OLP, and current off label treatments simply aren't designed or capable of providing therapeutic relief for wet tissue wounds," said Nishan de Silva, M.D., chief executive officer of AFYX Therapeutics. "Rivelin represents a major opportunity to benefit patients with mucosal diseases, starting with OLP, by providing the first therapeutic option specifically designed to treat their condition."

Rivelin Studies Presented at EAOM

Title: Update on the Development of a Novel Treatment for Oral Lichen Planus (OLP) – The Rivelin® Patch
Presenter: Richeal Ni Riordain, Cork University Dental School & Hospital

• Thirteen patients were enrolled in a Phase 1b study of the plain Rivelin patch in patients with OLP
• Rivelin patches were easy to apply when used twice daily for four weeks
• The adhesion time was generally longer than 15 minutes, as long as 120 minutes on the gingivae
• No patient-reported or clinician-reported adverse events or efficacy of the plain patch on the OLP lesions

Title: Electrospun Fibres Deliver Lidocaine to Porcine Buccal Mucosa: An Ex Vivo Permeation and MALDI-MS Imaging Study
Presenter: Katharina H. Clitherow, University of Sheffield

• Anesthetic lidocaine HCL delivered by electrospun fibers permeated through porcine buccal mucosa and was detectable after only 15 minutes
• Evidence of a time-dependent homogenous distribution of therapeutic through the epithelium and connective tissue
• Electrospinning allows manufacture and innovative therapeutic products for oral medicine, dentistry and surgery

Title: Unidirectional Delivery of Clobetasol-17-Propionate Using a Novel Muco-adhesive Bilayer Patch to Treat Oral Lichen Planus; a Pre-Clinical Evaluation
Presenter: Craig Murdoch, University of Sheffield

• Clobetasol-17-propionate was released from mucoadhesive patches in a sustained manner and penetrated tissue-engineered mucosa in a time and concentration-dependent profile without causing tissue toxicity.
• In vivo, drug loaded patches displayed prolonged residence time with drug release a therapeutically doses and without systemic or local toxicity
• Clobetasol-loaded electrospun muco-adhesive patches adhere to oral mucosal tissue release their therapeutic load and target T cell function without causing tissue damage

"Our research highlights the novelty of our electrospinning method for developing a two-layer muco-adhesive patch capable of sticking to wet surfaces while uni-directionally delivering a therapeutic load to the diseased tissue," added Dr. de Silva. "The electrospun Rivelin patch is an innovative approach for the local delivery of therapeutic products in oral medicine, dentistry and surgery."

Following their presentation at EAOM, posters will be available on the AFYX Therapeutics website at www.afyxtx.com.

About Oral Lichen Planus
Oral lichen planus (OLP) is a chronic inflammatory condition that affects the mucous surfaces of the oral cavity. OLP may appear as lesions in the mouth that may cause burning, pain and other discomfort. OLP requires regular monitoring given patients have increased risk of developing pre-cancerous cell changes including the development of mouth cancer. No U.S. Food and Drug Administration (FDA) approved treatment exists, with today's off-label treatment ranging from topical corticosteroids to laser ablation.

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. 

SOURCE AFYX Therapeutics

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