SAN DIEGO and COPENHAGEN, Denmark, May 23, 2019 /PRNewswire/ -- AFYX Therapeutics, a clinical stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced findings from the development of a novel Oral Lichen Planus Symptom Severity Measure (OLPSSM) as a tool used to assess patients' symptom experience on a daily basis. AFYX researchers and key opinion leaders found that the 7-item OLPSSM version 1.0 is a well-defined assessment tool to characterize the severity, specificity and variations in daily symptoms in patients with oral lichen planus (OLP), a painful chronic disease characterized by oral lesions. The assessment tool will be used in the development of Rivelin®-CLO, an oral adhesive clobetasol therapy being developed by AFYX. Findings were presented at the 2019 American Academy of Oral Medicine Annual Conference taking place in New Orleans, Louisiana.
"As we advance Rivelin-CLO in clinical development, it is important to develop a standard measurement tool that can assess the daily symptom experience of patients in order to reliably explore the impact of the treatment used to manage the symptoms of OLP," said Nishan de Silva, M.D., chief executive officer of AFYX Therapeutics. "We believe that the OLPSSM tool will provide important information on the treatment benefit to patients not only on Rivelin-CLO but for any intervention, and we are working closely with investigators and physicians in the field to advance this assessment tool and integrate into the development of Rivelin-CLO in Phase 2 clinical trials."
The study assessed OLPSSM, a patient-reported outcome measure that generates a score representing the daily variation in symptom severity as experienced and reported by patients diagnosed with OLP. Symptom journals, interviews and coding with respect to the patients' daily symptom experience were used throughout the 17 patient study and analyzed to determine that the final 7-item OLPSSM version 1.0 is a well-defined and reliable assessment tool for use in studies that will characterize the severity, specificity and variations in daily symptoms in patients with OLP.
The poster presented at AAOM 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.
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SOURCE AFYX Therapeutics