New treatment for oral lichen planus: successful multi-centre Phase II study opens door to Phase III

Researchers testing a new treatment for oral lichen planus have announced success in a commercial Phase II clinical trial featuring patients in both the US and Europe.

The study found that using a novel intraoral patch engineered to adhere to the oral mucosa and slowly deliver a potent corticosteroid 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.  

Eastman Primary Invesitigator Professor Stefano Fedele, said: “Oral Lichen Planus is a common chronic, inflammatory disease of the oral mucosa.

"It can cause long-standing painful ulceration in the mouth and notably reduce the quality of life of affected patients. 

“It is estimated to affect over six million patients in the U.S. and EU and yet there is no licensed treatment.

“We are indebted to our patients who participated in this trial and delighted to have contributed to the target recruitment with a significant number of participants from our hospital.  

"We look forward to the next step of testing this innovative therapeutic modality in a large global phase III trial, which - we believe - is in a very favourable position to become the first licensed treatment for this common and painful disease”.

The study was funded by Afyx Therapeutics and the recruitment of patients at UCLH RN ENT/EDH was also supported by additional funding of the NIHR Clinical Research Network and the NIHR UCLH Biomedical Research Centre. 

Read the press release from industry partner and project lead AFYX Therapeutics