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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

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.

Call for proposal

H2020-NMBP-2016-two-stage
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Coordinator

FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Address
Hansastrasse 27C
80686 Munchen
Germany
Activity type
Research Organisations
EU contribution
€ 783 095

Participants (11)

CONTIPRO AS
Czechia
EU contribution
€ 400 000
Address
Dolni Dobrouc 401
561 02 Dolni Dobrouc
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MYBIOTECH GMBH
Germany
EU contribution
€ 559 137,50
Address
Industriestrasse 1B
66802 Uberherrn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
HOCHSCHULE BIBERACH
Germany
EU contribution
€ 1 102 398,75
Address
Karlstrasse 11
88400 Biberach
Activity type
Higher or Secondary Education Establishments
ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS
Greece
EU contribution
€ 495 000
Address
Charilaou Thermi Road 6 Km
57001 Thermi Thessaloniki
Activity type
Research Organisations
BEITER GMBH GO KG
Germany
EU contribution
€ 728 125
Address
Scheererstrasse 7
72517 Sigmaringendorf
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LABORATORIO EUROPEO DI SPETTROSCOPIE NON LINEARI
Italy
EU contribution
€ 227 500
Address
Via Nello Carrara 1
50019 Sesto-fiorentino (Fi)
Activity type
Research Organisations
JENSONR+ LIMITED
United Kingdom
EU contribution
€ 611 700
Address
Fishleigh Court Fishleigh Road
EX31 3UD Barnstaple Devon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LGI SUSTAINABLE INNOVATION
France
EU contribution
€ 291 250
Address
6 Cite De L'ameublement
75011 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE EUROPEAN MULTIPLE SCLEROSIS PLATFORM AISBL
Belgium
EU contribution
€ 127 292,50
Address
Rue Auguste Lambiotte 144/8
1030 Bruxelles
Activity type
Other
NOVAGO THERAPEUTICS AG

Participation ended

Switzerland
EU contribution
€ 0
Address
Wagistrasse 27
8952 Schlieren
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITAET BERN
Switzerland
EU contribution
€ 0
Address
Hochschulstrasse 6
3012 Bern
Activity type
Higher or Secondary Education Establishments