Periodic Reporting for period 1 - BUCCAL-PEP (Development of a multifunctional biomaterial patch for buccal delivery of peptide-analogue treatments)
Reporting period: 2023-01-01 to 2024-06-30
BUCCAL-PEP brings together a European team of academics and industrial researchers to address the challenge of creating alternative drug administration routes for large molecules such as peptides (for example, insulin). These drugs are normally administered by injections, although recent achievements have resulted in two peptides that can be administered orally administered. With these orally administered peptides, however patients must wait 30 minutes before eating and drinking. This can be an inconvenience for patients taking tablets or capsules every day. We aim with the BUCCAL-PEP project to design a patch system that will be applied daily to the inside of the cheek to deliver peptides. Advantages of a buccal system are that it may deliver more peptide to the blood than via the oral route because the cheek has high permeability. In addition, the buccal route avoids the liver, which is designed to break peptides down. Finally, the patches will be designed to dissolve within a few minutes and therefore patients will not have to wait long to eat and drink. Oral thin films designed to stick to the cheek have been designed before for small molecules by one of our partners. These films will, however not work for the larger peptides as they are prone to breakdown and also require assistance to cross the cheek into the blood. In BUCCAL-PEP, the team will work on a peptide similar to Glucagon-like-peptide 1 (GLP-1), semaglutide. Semaglutide is approved for Type II diabetes as a once weekly injection and as a daily tablet. We will incorporate a semaglutide analogue into a new patch system with agents to both protect it from breakdown and enhance its capacity to cross the cheek to the blood. The patch will be made in layers by 3D-printing and tested in pigs to see if it delivers the peptide to the blood without damaging the cheek. If successful, the project will move forward into providing further options for patients with Type II diabetes in terms of convenience of drug administration, while at the same time enhancing the European pharmaceutical industry.
In the first 6 months of the BUCCAL-PEP, the following has been achieved:
- KO meeting in Dublin in January
- Consortium Agreement signed by all partners
- Data Management Plan accepted by the EU
- Most PhDs and postdocs have been hired
- The website and logo have been launched
- Synthesis of initial prototype mucoadhesive patches achieved by 3D printing (technical)
- Fluxes have been initiated in isolated pig buccal tissue mounted in chambers (technical)
- Establishment of the TR146 human buccal epithelial cell line for flux and cytotoxicity studies (technical)
- Ethics application drafted for the animal studies at Charite, Berlin
- Visit by UCD and TDU researchers to Adhex Pharma in Dijon in July for technical discussions
- Advanced discussions with a Hop-On partner from Portugal for September submission
- KO meeting in Dublin in January
- Consortium Agreement signed by all partners
- Data Management Plan accepted by the EU
- Most PhDs and postdocs have been hired
- The website and logo have been launched
- Synthesis of initial prototype mucoadhesive patches achieved by 3D printing (technical)
- Fluxes have been initiated in isolated pig buccal tissue mounted in chambers (technical)
- Establishment of the TR146 human buccal epithelial cell line for flux and cytotoxicity studies (technical)
- Ethics application drafted for the animal studies at Charite, Berlin
- Visit by UCD and TDU researchers to Adhex Pharma in Dijon in July for technical discussions
- Advanced discussions with a Hop-On partner from Portugal for September submission
Not applicable at this stage of the project.