Preclinical study demonstrates potential to deliver anti-TNFα antibody fragments topically to inflamed mucosal tissue using Rivelin technology
SAN DIEGO & COPENHAGEN, Denmark–(BUSINESS WIRE)–AFYX Therapeutics (“AFYX”), a clinical-stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, announced results from a preclinical study from the company’s collaboration with the University of Sheffield in the UK exploring the potential effects of delivering antibody fragments directly to inflamed tissue in mucosal diseases using Rivelin® technology. The preclinical study demonstrated for the first time that the company’s Rivelin technology is capable of delivering biologic drugs. The study showed that a) the company’s proprietary Rivelin patch was formulated with therapeutic anti-TNFα antibody fragments, b) those fragments were successfully delivered directly to inflamed mucosal tissue, and c) that the antibodies maintained a neutralizing effect on inflammatory cells. These data were presented by investigators from the University of Sheffield at the BioMedEng21 Annual Conference.
AFYX has developed the Rivelin patch for delivery of therapeutics to wet tissue surfaces such as the oral mucosa. In a Phase 2 study presented at the AAOM 2021 Conference, Rivelin-CLO 20-μg dose demonstrated a statistically significant improvement in ulcer size in patients with oral lichen planus – a condition for which no FDA approved therapy exists despite affecting more than 1% of the US population.
“The recent presentation features the first Rivelin study demonstrating the potential to deliver not only small molecules but also proteins – in this case anti-TNFα antibody fragments. Delivering antibodies to target inflammatory disease in the oral mucosa using the Rivelin patch technology allows the development of new, locally-delivered therapies for mucosal diseases that currently can only be addressed with systemic treatment modalities,” said Nishan de Silva, M.D., CEO of AFYX Therapeutics. “Future studies will evaluate higher doses with potential to achieve complete neutralization, and will aim to deliver anti-TNFα fragments topically to inflamed tissue in oral mucosal models.”
In the study, researchers showed that a biotinylated F(ab) fragment was electrospun into the existing Rivelin formulation and released to target tissue while maintaining antigen-binding activity. The study demonstrated that a low dose (18.9 ng/mg) of anti-TNF F(ab)s reduced IL8 expression to a greater extent than the placebo, showing that the F(ab) maintained neutralizing activity following release.
A copy of the presentation, titled “Delivery of Therapeutic F(ab) antibody fragments to the Oral Mucosa Using Electrospun Patches,” 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 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 oral lichen planus 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 2 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.
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Canale Communications
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