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Nose to Brain Delivery of NG-101 via the Olfactory Region for the Regenerative Treatment of Multiple Sclerosis Using Novel Multi-functional Biomaterials Combined with a Medical Device

Nose to Brain Delivery of NG-101 via the Olfactory Region for the Regenerative 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.
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Coordinator

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Address

Hansastrasse 27c
80686 Munchen

Germany

Activity type

Research Organisations

EU Contribution

€ 783 095

Participants (10)

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CONTIPRO AS

Czechia

EU Contribution

€ 400 000

MJR PHARMJET GMBH

Germany

EU Contribution

€ 559 137,50

HOCHSCHULE BIBERACH

Germany

EU Contribution

€ 1 102 398,75

ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS

Greece

EU Contribution

€ 495 000

BEITER GMBH GO KG

Germany

EU Contribution

€ 728 125

LABORATORIO EUROPEO DI SPETTROSCOPIE NON LINEARI

Italy

EU Contribution

€ 227 500

JENSONR+ LIMITED

United Kingdom

EU Contribution

€ 611 700

LGI CONSULTING

France

EU Contribution

€ 291 250

THE EUROPEAN MULTIPLE SCLEROSIS PLATFORM AISBL

Belgium

EU Contribution

€ 127 292,50

NOVAGO THERAPEUTICS AG

Switzerland

Project information

Grant agreement ID: 721098

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2020

Funded under:

H2020-EU.2.1.3.

  • Overall budget:

    € 6 472 998,75

  • EU contribution

    € 5 325 498,75

Coordinated by:

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany