Nose-to-Brain-patch

A breakthrough approach

Nose to Brain Delivery of Antibodies via the Olfactory Region for the Treatment of Multiple Sclerosis Using Novel Multifunctional Biomaterials Combined with a Medical Device

Our EU-funded research involves an innovative method of bypassing the blood brain barrier by delivering a potential MS drug with a special medical device via the nose directly to the brain!

N2B-patch - Final Video

After 4,5 years, the N2B-patch project officially ends by the end of June 2021.

In a final project video, the consortium sheds light on the objectives, the challenges and the advantages that a direct transport route from the nasal cavity to the brain, bypassing the blood-brain barrier, could potentially offer for central nervous system drug delivery. Moreover, the latest results of the proof of concept study are presented by the N2B-patch team.

The further development of platform technology for the treatment of other CNS disorders continues beyond the end of the project.

Exciting innovation: Nose to Brain drug delivery

The direct transport route from the nasal cavity to the brain, bypassing the blood-brain barrier, could potentially offer an exciting method for central nervous system drug delivery. It may be used not only for demyelinating disorders such as MS but also for other neurological and neurodegenerative indications or tumours.

The N2B-patch team will deliver a proof of concept of its therapeutic potential as well as a preclinical validation. Science, industry and patients’ representatives work hand in hand in order to achieve the project objectives and maximise impact for patients and their relatives, health professionals and European industries. They are guided by regulatory and business exploitation experts.

Expected timeline

The development of a new drug generally requires several years of intensive research and validation. The N2B-patch team starts its work in the laboratory and ends in proof of concept and pre-clinical validation. Once the pre-clinical validation will be successfully completed, the team is keen to strive for the next step, which will then be the start of the clinical validation.

Research | Proof-of-concept | Pre-clinical validation

2017 - 2020

Research on new starting-points for drugs

Identification and preselection of substances

Examination of effects and sideeffects

Clinical validation

Phase I Compatibility tests with few healthy people

Phase II
Tests with few patients

Phase III
Tests with several thousands of patients

Registration

Application for Marketing Authorisation

Who we are

We are a complementary and international team of eleven partners from science and industry. Fraunhofer (DE), Europe’s largest organisation for applied research, coordinates the project. Five small and medium sized enterprises come from the field of hydrogel technology & manufacturing (CZ), particle technology & manufacturing (DE), construction & moulding (DE), regulatory affairs (UK) and consultancy (FR). Further team members are academic experts for biopharmaceutical N2B delivery (DE), neuroscience (CH), numerical simulation (GR) and protein integrity (IT) as well as the European MS Platform representatives (BE).

What we do

We aim to develop an innovative N2B drug delivery technology for the treatment of MS based on the synthesis of a biomaterial-based innovative galenic formulation, a novel class of hydrogel matrix-patch and a medical applicator device system. The N2B route of administration provides a minimally invasive method of bypassing the blood-brain-barrier (BBB). Moreover, the innovative multifunctional galenic formulation of N2B-patch aims to shield sensitive drugs and maintain the drug’s bioactivity.

N2B-patch ended successfully

The N2B-patch project ended successfully in June 2021. We would like to thank all project .....

N2B-patch Final Symposium on 17 June 2021

Save the date! Our virtual N2B-patch Symposium will take place on 17 June 2021. Stay .....

N2B-patch advantages

N2B-patch has a huge potential of contributing to the sustainability and efficiency of European health care systems as well as to a positive and meaningful change for the benefit of society. We have summarized the most important advantages for you here.

Further information for Patients

Multiple sclerosis is one of the most common long-term conditions affecting the central nervous system and the main cause of non-traumatic disability in young adults. It affects more than 700,000 people in Europe. It is a neurodegenerative disease; a group of conditions that also includes Parkinson’s and Alzheimer’s diseases. Our N2B-patch drug-device combination may reduce the number of applications needed and make the medical therapy as easy as possible and more comfortable for patients and their surroundings. This may increase independence and improve personalized medicine of patients.

For Patients

Further information for Researchers

Our innovative minimally invasive N2B-patch system may ensure a highly reproducible central bioavailability of the innovative and clinically established biopharmaceutical for remyelination. Since the cribriform plate is a very sensitive part of the skull base, the intranasal applicator system may not be allowed to come too close to this delicate area.

For Researchers