About our project
background
Current challenges
Oral delivery of peptide-analogues (a macromolecule) is one of the great challenges in pharmaceutical research. Thus far, only five peptide analogues have been converted to oral formulations such as tablets/capsules and all face distinct challenges including low bioavailability, dosage control, patient administration inconvenience and restrictions in use (e.g. undesirable food interactions).
Our goals
Our solution
The BUCCAL-PEP consortium will join hands to develop a multifunctional biomaterial patch which allows, for the first time, buccal (in the cheek) delivery of peptide-analogue therapies, thereby overcoming these challenges through unique integration of a permeation enhancer (SDC) with biomaterials and a peptide-analogue. The novel formulation enables peptides to diffuse across the mucosal multilayer, thereby effectively achieving their intended pharmacological response. The novel approach will result in an improved quality of patient life and increased treatment compliance.
- Develop a multifunctional biomaterial patch
- Unique integration of permeation enhancer (SDC) with biomaterials and peptide-analogue
- In-cheek (buccal) delivery of peptide-analogue therapies
- Increased treatment compliance and improved quality of life
our work
Our approach
Within this project, the consortium will design, select and manufacture a lead product (with Type 2 Diabetes as showcase indication) that will be validated for performance in in vivo large animal studies. Additionally, a Health Technology Assessment will be performed to support the development an evidence-based value proposition and aid in the development of a commercialisation strategy. The final deliverable of the project is a patch that is pre-clinically validated and ready for clinical trials in the desired showcase indication. peptides to diffuse across the mucosal multilayer, thereby effectively achieving their intended pharmacological response. The novel approach will result in an improved quality of patient life and increased treatment compliance.
The work has been structured in different work packages:
This work package aims to develop a patch that can deliver semaglutide through the buccal or sub-lingual route by optimizing the combination of different materials and ratios. The performance of at least 10 prototypes will be assessed in vitro, ex vivo, and in vivo in porcine models before selecting a candidate patch for further testing.
The project will perform in vivo absorption tests on two lead patch prototypes developed in WP1 on the buccal or sub-lingual mucosa in pigs. They will analyze PK-PD data from blood samples collected during intravenous administration and buccal absorption tests and provide feedback to WP3. The study will also evaluate the safety of buccal and sub-lingual mucosa using histological analysis in cross-over pig studies.
This work package will optimize the three-layer design of the patch, including the concentrations of components, layer thickness, mucoadhesion, and maximum loadings, and select a scalable process for production. They will assess the selected process using ex vivo flux of semaglutide from loaded films and establish target specifications for the patch for the in vivo porcine study.
This work package’s main objective is to develop a business plan for the proposed technology platform by conducting a health economics and market assessment. This includes analyzing the target population segment, assessing the commercial viability and return of investment compared to the standard of care, and developing a comprehensive business plan for the first target indication while also exploring the technology’s potential for other indications of interest.
The objective of this work package is to ensure effective communication and dissemination of the project’s developments to stakeholders, including scientific community, industry, clinical experts, patients, and caregivers. The goals are to engage all stakeholders, consider their needs, communicate project progress and results to the general public, and develop a solid foundation for the exploitation strategy of the novel technology.
The main objective of work package 6 is to ensure productive project execution and realisation of main objectives in time and within budget. It is also important to ensure performance of activities by project partners and reporting according to EC regulations.
