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Treating Oral Lichen Planus with patches

Professor Stefano Fedele with AFYX LtD

Oral Lichen Planus is a chronic, inflammatory disease causing white patches and painful ulcers in the mouth. It is estimated to affect 1% of the population, or over six million patients in the U.S. and EU. There is no approved treatment for oral lichen planus and most patients currently are given unlicensed creams and mouthwashes containing corticosteroids. 

Activities

This study is investigating the efficacy of a novel mucosal adhesive patch (Rivelin CLO®)* with slow-delivery of a potent corticosteroid agent in controlling painful symptoms and inducing healing of painful ulcers of the skin of the mouth caused by oral lichen planus. 

In April 2020 study leads AFYX Therapeutics reported success in the Phase II clinical trial featuring patients in both the US and Europe. It was found that the slow delivery of the agent led to statistically significant improvement in the painful ulcers caused by the disease.

A total of 138 patients were recruited, with the Oral Medicine clinic at the UCLH Royal National ENT & Eastman Dental Hospitals recruiting the first European patient and being the biggest recruiter in the UK and second in Europe overall.

This success opens the door to a Phase III study. Read more  

Potential impact

This study has the potential to revolutionise the treatment of oral lichen planus as currently there is no therapeutic agent that has been approved and licensed for this indication.