The preclinical study shows potential to deliver anti-TNFα antibody fragments to inflamed mucosal tissue using Rivelin technology
Rivelin Patch shows superior results in preclinical study. (Credit: Chokniti Khongchum from Pixabay.)
AFYX Therapeutics has unveiled positive results from a preclinical study, exploring the potential of its Rivelin patch technology in delivering antibody fragments.
The study, conducted in collaboration with the UK’s University of Sheffield, evaluated Rivelin for delivering the antibody fragments directly to inflamed tissue to treat mucosal diseases.
Rivelin is a mucoadhesive two-layered patch that delivers a pharmaceutical product directly to wet tissue surfaces.
Leveraging a unique patch technology, Rivelin adheres to mucosal surfaces for long periods and facilitates uni-directional delivery of a pharmaceutical agent selectively to the target site.
The patch is designed to limit the delivery of drug substances to areas surrounding the target site, enabling high efficacy, low dosing and less toxicity to non-affected parts.
AFYX Therapeutics CEO Nishan de Silva said: “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.
“Future studies will evaluate higher doses with potential to achieve complete neutralisation, and will aim to deliver anti-TNFα fragments topically to inflamed tissue in oral mucosal models.”
In the study, the Rivelin patch was formulated with therapeutic anti-TNFα antibody fragments, where a biotinylated F(ab) fragment was electrospun into the existing Rivelin formulation.
The results showed that the antibodies were delivered directly to inflamed mucosal tissue, while maintaining antigen-binding activity.
Also, a low dose of anti-TNF F(ab)s reduced IL8 expression compared to placebo, showing that the F(ab) maintained neutralising activity on inflammatory cells, after release.
AFYX said that the preclinical study, for the first time, showed that the Rivelin technology is capable of delivering biologic drugs.
Also, the technology would significantly improve the treatment model for oral lichen planus and other inflammatory mucosal diseases.
In a Phase 2 study, Rivelin-CLO 20-μg dose showed a statistically significant improvement in ulcer size in patients with oral lichen planus, a condition with no FDA approved therapy.