A novel spray delivery system for the treatment of mucosal scarring in epidermolysis bullosaOngoing
|Project lead||Prof. Liam Grover|
|Organisation||University of Birmingham|
|Partner organizations & collaborators||Co investigators: Professor Anthony Metcalfe, School of Chemical Engineering & Institute of Inflammation & Ageing and Professor Iain Chapple, School of Dentistry, University of Birmingham and Professor Adrian Heagerty, Institute of Ageing and Inflammation, University of Birmingham and Dermatologist, Solihull hospital |
Collaborator: Professor Alan Smith, Director of Biopolymer Research Centre, University of Huddersfield
|Project budget||GBP 179,277.02|
|Start date / Duration||01. Sep 2020 / 24 months|
|Funder(s) / Co-Funder(s)||DEBRA UK, DEBRA Ireland, MSAP/EBEP Recommended|
|Research area||Symptom prevention & relief|
Short lay summary
This project will work towards the development of a new spray delivery system as both a treatment and preventive strategy for scarring that affects the mucosa or membranes in the body which characterises EB, and the associated morbidity. The overall aim will be to formulate this delivery system so that it can be used to deliver three candidate anti-fibrotic molecules. Importantly, the final output of the project will be three systems formulated and manufactured in a way that would allow them to be used in a comparative clinical trial, which will be funded either commercially or through an additional grant application
1. Formulate, with clinicians and patient groups, an oral spray that can be used for delivery into the buccal (cheek) cavity.
2. Absorb therapeutic antifibrotic molecules into this material and demonstrate their retained therapeutic potency during a period of storage and then spraying.
3. Develop a GMP (Good Manufacturing Practice) process for manufacture and filling of the drug containing materials.
4. Put in place the paperwork required for a phase I trial of the oral preparation.
All of the above objectives are achievable in a two-year project given that they have 1) undertaken the basic preparation of a spray-based gel technology, and 2) developed GMP processes to manufacture the material that we propose to use for spraying. Furthermore, they have already undertaken biocompatibility testing of the materials in-line with ISO 10993 (an industry standard for biological testing, risk management and evaluation), and have performed human contact trials in intact skin. Both enabling the use of the preparations in the relatively short term.
Epidermolysis Bullosa (EB) is a group of genetic skin conditions that cause the skin and mucous membranes to blister. EB is characterised by fragile skin and in some cases, internal organs and linings can be affected. This research aims to develop a spray to deliver anti-fibrotic molecules to treat and formulate a preventative strategy to combat the scarring that affects the mucosa in EB patients.