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N2B-patch SIGNED

Nose to Brain Delivery of antibodies via the Olfactory Region for the Treatment of Multiple Sclerosis Using Novel Multi-functional Biomaterials Combined with a Medical Device

Total Cost €

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EC-Contrib. €

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Partnership

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Outcomes and
results

N2B-patch project word cloud

Explore the words cloud of the N2B-patch project. It provides you a very rough idea of what is the project "N2B-patch" about.

invasive synthesis antagonist remyelation cns practical drug blocking disorders medical 101 hyaluronic polymer initial container n2b monoclonal ccs galenic nasal data onto polylactic central contact consist adhesion bbb glycolic aid api device route ingredient direct ms transport region nervous closure brain spinal proven acid biomaterial equipped integrity stroke nogoa offers proof ph cavity chitosan deposited mucoadhesive demyelinating particle patch loaded apis bypassing diseases neurodegenerative innovative bioavailabilty tumours epithelium sufficiently pharmaceutical ng biodegradable mode exploited bioavailability safe cross matrix mab active drugs cord particles co minimally permeation treatment formulation plga indications chronic sustainable clinical enormous environment olfactory coating release largely subsequent derivatives hydrogel axonal platform antibodies sensitive

Project "N2B-patch" data sheet

The following table provides information about the project.

Coordinator	FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. Organization address address: HANSASTRASSE 27C city: MUNCHEN postcode: 80686 website: www.fraunhofer.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Germany [DE]
Project website	https://n2b-patch.eu/
Total cost	6˙472˙998 €
EC max contribution	5˙325˙498 € (82%)
Programme	1. H2020-EU.2.1.3. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials)
Code Call	H2020-NMBP-2016-two-stage
Funding Scheme	RIA
Starting year	2017
Duration (year-month-day)	from 2017-01-01 to 2020-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. Organization address address: HANSASTRASSE 27C city: MUNCHEN postcode: 80686 website: www.fraunhofer.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUNCHEN)	coordinator	783˙095.00
2	HOCHSCHULE BIBERACH HOCHSCHULE BIBERACH Organization address address: KARLSTRASSE 11 city: BIBERACH postcode: 88400 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BIBERACH)	participant	1˙102˙398.00
3	BEITER GMBH GO KG BEITER GMBH GO KG Organization address address: SCHEERERSTRASSE 7 city: SIGMARINGENDORF postcode: 72517 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (SIGMARINGENDORF)	participant	728˙125.00
4	JENSONR+ LIMITED JENSONR+ LIMITED Organization address address: FISHLEIGH COURT FISHLEIGH ROAD city: BARNSTAPLE DEVON postcode: EX31 3UD website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BARNSTAPLE DEVON)	participant	611˙700.00
5	MJR PHARMJET GMBH MJR PHARMJET GMBH Organization address address: INDUSTRIESTRASSE 1B city: UBERHERRM postcode: 66802 website: www.mjr-pharmjet.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (UBERHERRM)	participant	559˙137.00
6	ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS Organization address address: CHARILAOU THERMI ROAD 6 KM city: THERMI THESSALONIKI postcode: 57001 website: www.certh.gr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (THERMI THESSALONIKI)	participant	495˙000.00
7	CONTIPRO AS CONTIPRO AS Organization address address: DOLNI DOBROUC 401 city: DOLNI DOBROUC postcode: 561 02 website: www.contipro.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CZ (DOLNI DOBROUC)	participant	400˙000.00
8	LGI CONSULTING LGI CONSULTING Organization address address: 6 CITE DE L'AMEUBLEMENT city: PARIS postcode: 75011 website: www.lgi-consulting.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	291˙250.00
9	LABORATORIO EUROPEO DI SPETTROSCOPIE NON LINEARI LABORATORIO EUROPEO DI SPETTROSCOPIE NON LINEARI Organization address address: Via Nello Carrara 1 city: Sesto-Fiorentino (FI) postcode: 50019 website: www.lens.unifi.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (Sesto-Fiorentino (FI))	participant	227˙500.00
10	THE EUROPEAN MULTIPLE SCLEROSIS PLATFORM AISBL THE EUROPEAN MULTIPLE SCLEROSIS PLATFORM AISBL Organization address address: RUE AUGUSTE LAMBIOTTE 144/8 city: BRUXELLES postcode: 1030 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUXELLES)	participant	127˙292.00
11	NOVAGO THERAPEUTICS AG NOVAGO THERAPEUTICS AG Organization address address: WAGISTRASSE 27 city: SCHLIEREN postcode: 8952 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (SCHLIEREN)	participant	0.00
12	UNIVERSITAET BERN UNIVERSITAET BERN Organization address address: HOCHSCHULSTRASSE 6 city: BERN postcode: 3012 website: http://www.unibe.ch contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BERN)	participant	0.00

Map

Project objective

The overall aim of N2B-patch is the development of a new innovative N2B drug delivery technology based on the synthesis of a biomaterial-based innovative galenic formulation that will be applied with the aid of a novel medical device equipped with a container closure system (CCS) as a hydrogel patch to the nasal olfactory region for the chronic treatment of MS. The galenic formulation will consist of drug loaded biodegradable polymer particles (e.g., chitosan, polylactic-co-glycolic acid, PLGA) embedded into a biodegradable hydrogel matrix (e.g., hyaluronic acid (HA)-based) to be deposited as a patch onto the olfactory region. A pH-sensitive, mucoadhesive particle coating (e.g., chitosan, chitosan derivatives) will ensure an environment-specific adhesion to the olfactory epithelium. This novel technology will largely enhance the controlled and sustainable delivery of drugs and increase the drug bioavailabilty to the CNS. NogoA antagonist NG-101 will be used as an active pharmaceutical ingredient (API). Proof of concept studies and initial clinical data have proven the enormous potential of blocking NogoA for spinal cord remyelation and axonal integrity. However, monoclonal antibodies (mAb) like NG-101, do not sufficiently cross the BBB. The sustainable and controlled release of NG-101 to the CNS will be achieved via the transport of embedded polymer particles to the olfactory epithelium, the subsequent release of API and permeation through the olfactory region, the only part of the nasal epithelium which is in direct contact with the brain. The direct transport route from the nasal cavity to the brain, bypassing the BBB, offers an exciting mode of central nervous system (CNS) drug delivery not only for demyelinating disorders but also for other CNS indications, e.g., stroke, neurodegenerative diseases or tumours. The proposed new innovative N2B drug delivery platform is a practical, safe, and minimally invasive technology. It will be exploited for NG-101 and has the potential to be implemented with other APIs with a low CNS bioavailability.

Publications

List of publications.
year	authors and title	journal	last update
2019	Simone Ladel, Patrick Schlossbauer, Johannes Flamm, Harald Luksch, Boris Mizaikoff, Katharina Schindowski Improved In Vitro Model for Intranasal Mucosal Drug Delivery: Primary Olfactory and Respiratory Epithelial Cells Compared with the Permanent Nasal Cell Line RPMI 2650 published pages: 367, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11080367	Pharmaceutics 11/8	2020-04-14
2018	Aleck H. Alexopoulos, Costas Kiparissides A Computational Model for the Analysis of Spreading of Viscoelastic Droplets over Flat Surfaces published pages: 78, ISSN: 2311-5521, DOI: 10.3390/fluids3040078	Fluids 3/4	2020-04-14
2018	Simone Ladel, Johannes Flamm, Arghavan Soleimani Zadeh, Dorothea Filzwieser, Julia-Christina Walter, Patrick Schlossbauer, Ralf Kinscherf, Katharina Lischka, Harald Luksch, Katharina Schindowski Allogenic Fc Domain-Facilitated Uptake of IgG in Nasal Lamina Propria: Friend or Foe for Intranasal CNS Delivery? published pages: 107, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics10030107	Pharmaceutics 10/3	2020-04-14
2018	Bourganis, Vassilis; Kammona, Olga; Alexopoulos, Aleck; Kiparissides, Costas Recent advances in carrier mediated nose-to-brain delivery of pharmaceutics published pages: 337-362, ISSN: 0939-6411, DOI: 10.5281/zenodo.1256646	European Journal of Pharmaceutics and Biopharmaceutics 128	2020-04-14
2018	Gruber-Traub C, Ullrich J. Â»N2B-PatchÂ« â€“ Nose-to-Brain Delivery of an Active Pharmaceutical Ingredient via the Olfactory Region published pages: , ISSN: 2637-4706, DOI:	Drug Designing & Intellectual Properties International Journal	2020-04-14
2018	Stella GÃ¤nger, Katharina Schindowski Tailoring Formulations for Intranasal Nose-to-Brain Delivery: A Review on Architecture, Physico-Chemical Characteristics and Mucociliary Clearance of the Nasal Olfactory Mucosa published pages: 116, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics10030116	Pharmaceutics 10/3	2020-04-14

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