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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.

Field of science

  • /medical and health sciences/health sciences/infectious disease/RNA virus/hiv
  • /natural sciences/biological sciences/cell biology/cell signaling
  • /medical and health sciences/medical biotechnology/medical bioproducts/implants

Call for proposal

H2020-PHC-2014-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

AUDION THERAPEUTICS BV
Address
Linnaeusparkweg 10-2
1098 EA Amsterdam
Netherlands
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 821 330,81

Participants (8)

UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 1 051 188,58
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
EU contribution
€ 331 250
Address
Geschwister-scholl-platz
72074 Tuebingen
Activity type
Higher or Secondary Education Establishments
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 287 466,68
Address
6 Christou Lada Str
10561 Athina
Activity type
Higher or Secondary Education Establishments
Eli Lilly and Company Limited
United Kingdom
EU contribution
€ 1 347 362,50
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LINICAL NETHERLANDS B.V.

Participation ended

Netherlands
EU contribution
€ 1 771,25
Address
Victorialaan 15
5213 JG 'S-hertogenbosch
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TTOPSTART BV
Netherlands
EU contribution
€ 125 000
Address
Euclideslaan 1
3584 BL Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NORDIC BIOSCIENCE CLINICAL DEVELOPMENT A/S
Denmark
EU contribution
€ 715 818,50
Address
Herlev Hovedgade 207
2730 Herlev
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 153 151,68
Address
Euston Road 250
NW1 2PG London
Activity type
Research Organisations