Skip to main content

REgeneration of inner ear hair cells with GAmma-secretase INhibitors to regain hearing in patients with sensorineural hearing loss

Objective

Hearing loss is a chronic non-communicable disease disabling over 328 million adults, and 32 million children worldwide. Sensorineural hearing loss due to loss of auditory hair cells was long thought to be irreversible. However, recent animal studies have demonstrated that pharmacological inhibition of cell signalling via Notch receptors using gamma-secretase inhibitors (GSIs) can regenerate hair cells and partially restore hearing capacity. This novel therapeutic concept provides the first promising lead for actual treatment of hearing loss. Clinical validation of these findings is the next crucial stepping stone in the development of a regenerative therapy for hearing loss. The ambition of REGAIN is to repurpose a GSI molecule for this indication by shifting from systemic to local treatment.
The objective of the REGAIN project is to demonstrate and exploit the efficacy of locally administered GSIs to improve hearing through regeneration of inner ear hair cells with a lasting effect. The project will involve 1) the upscaling of GMP production of the clinical GSI candidate, 2) the generation of preclinical data on GSI dosing and local safety, 3) medical ethical clinical trial approval and 4) the demonstration of proof of concept for GSI for treatment of patients with recent onset sensorineural hearing loss.
Small molecule drugs targeting the underlying biological causes of hearing loss in a safe way are expected to meet a real medical need for millions of patients, who currently rely on the limited benefits provided by hearing aids or cochlear implants. The partners involved in REGAIN represent the current state of the art in regenerative hearing loss research in the EU. REGAIN will break through that current state of the art, and will advance the first highly promising pharmaceutical treatment of hearing loss through clinical testing.

Call for proposal

H2020-PHC-2014-2015

See other projects for this call

Sub call

H2020-PHC-2014-two-stage

Coordinator

AUDION THERAPEUTICS BV
Net EU contribution
€ 1 821 330,81
Address
Linnaeusparkweg 10-2
1098 EA Amsterdam
Netherlands

See on map

Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,25

Participants (8)

UNIVERSITY COLLEGE LONDON
United Kingdom
Net EU contribution
€ 1 051 188,58
Address
Gower Street
WC1E 6BT London

See on map

Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
Net EU contribution
€ 331 250,00
Address
Geschwister-scholl-platz
72074 Tuebingen

See on map

Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
Net EU contribution
€ 287 466,68
Address
6 Christou Lada Str
10561 Athina

See on map

Region
Κεντρικός Τομέας Αθηνών Aττική Αττική
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ELI LILLY AND COMPANY LTD
United Kingdom
Net EU contribution
€ 1 347 362,50
Address
Lilly House Basingview
RG21 4FA Basingstoke

See on map

Region
South East (England) Hampshire and Isle of Wight North Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
LINICAL NETHERLANDS B.V.

Participation ended

Netherlands
Net EU contribution
€ 1 771,25
Address
Victorialaan 15
5213 JG 'S-hertogenbosch
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Noord-Brabant Noordoost-Noord-Brabant
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
TTOPSTART BV
Netherlands
Net EU contribution
€ 125 000,00
Address
Laan Van Zuid Hoorn 15
2289 DC Rijswijk

See on map

Region
West-Nederland Zuid-Holland Agglomeratie ’s-Gravenhage
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
NORDIC BIOSCIENCE CLINICAL DEVELOPMENT A/S
Denmark
Net EU contribution
€ 715 818,50
Address
Herlev Hovedgade 207
2730 Herlev

See on map

SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Danmark Hovedstaden Københavns omegn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 153 151,68
Address
Euston Road 250
NW1 2PG London

See on map

Region
London Inner London — West Camden and City of London
Activity type
Research Organisations
Other funding
€ 0,00