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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

Objetivo

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.

Convocatoria de propuestas

H2020-NMBP-2016-two-stage
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Coordinador

FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Dirección
Hansastrasse 27C
80686 Munchen
Alemania
Tipo de actividad
Research Organisations
Aportación de la UE
€ 783 095

Participantes (11)

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

La participación finalizó

Suiza
Aportación de la UE
€ 0
Dirección
Wagistrasse 27
8952 Schlieren
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITAET BERN
Suiza
Aportación de la UE
€ 0
Dirección
Hochschulstrasse 6
3012 Bern
Tipo de actividad
Higher or Secondary Education Establishments