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Development of a multifunctional biomaterial patch for buccal delivery of peptide-analogue treatments

Objective

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).

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.

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.

Overall, the BUCCAL-PEP project will provide a platform technology for oromucosal delivery of peptide-analogues that will be suitable for a broad range of experimental- and approved peptides-analogues therapies across a multitude of disease indications. BUCCAL-PEP will enable novel peptide-based treatments to emerge, which otherwise might not have reached the market due to incompatibility with the currently available administration routes.

Coordinator

UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Net EU contribution
€ 586 896,00
Address
Belfield
4 Dublin
Ireland

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,25

Participants (5)

DANMARKS TEKNISKE UNIVERSITET
Denmark
Net EU contribution
€ 612 422,00
Address
Anker Engelunds Vej 101
2800 Kongens Lyngby

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Region
Danmark Hovedstaden Københavns omegn
Activity type
Higher or Secondary Education Establishments
Other funding
€ 11,75
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
Net EU contribution
€ 685 211,00
Address
Chariteplatz 1
10117 Berlin

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,25
ADHEXPHARMA
France
Net EU contribution
€ 713 437,50
Address
Rue De Lubeck 30
75016 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
NOVO NORDISK A/S
Denmark
Net EU contribution
€ 430 687,50
Address
Novo Alle 1
2880 Bagsvaerd

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Region
Danmark Hovedstaden Københavns omegn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Catalyze B.V.
Netherlands
Net EU contribution
€ 343 125,00
Address
Joop-geesinkweg 167
1114 AB Amsterdam-duivendrecht

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00

Partners (1)

CAMBRIDGE INNOVATION TECHNOLOGIES CONSULTING LIMITED
United Kingdom
Net EU contribution
€ 0,00
Address
St John's Innovation Centre Cowley Road
CB4 0WS Cambridge

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East of England East Anglia Cambridgeshire CC
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
No data