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

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.
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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

€ 1 512 500

Participants (7)

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UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 1 204 340

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 368 125

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 368 125

Eli Lilly and Company Limited

United Kingdom

EU Contribution

€ 1 347 362,50

ACCELOVANCE EUROPE BV

Netherlands

EU Contribution

€ 1 771,25

TTOPSTART BV

Netherlands

EU Contribution

€ 125 000

NORDIC BIOSCIENCE CLINICAL DEVELOPMENT A/S

Denmark

EU Contribution

€ 907 116,25

Project information

Grant agreement ID: 634893

Status

Ongoing project

  • Start date

    1 May 2015

  • End date

    31 October 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 834 340,25

  • EU contribution

    € 5 834 340

Coordinated by:

AUDION THERAPEUTICS BV

Netherlands