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REGAIN SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

REGAIN project word cloud

Explore the words cloud of the REGAIN project. It provides you a very rough idea of what is the project "REGAIN" about.

disease onset disabling lasting implants sensorineural inhibitors shifting patients break receptors indication adults gsi thought causes benefits regenerative therapy administered preclinical gsis medical molecule ambition inner restore ear efficacy clinical underlying gmp 32 trial proof drugs actual auditory dosing animal generation hair pharmaceutical systemic locally aids rely limited safe signalling capacity cochlear repurpose therapeutic biological 328 small stepping hearing local effect gamma data cell demonstration notch children worldwide approval first validation safety chronic million regenerate irreversible cells stone involve communicable candidate meet millions upscaling pharmacological treatment regain regeneration provides secretase inhibition demonstrated ethical

Project "REGAIN" data sheet

The following table provides information about the project.

Coordinator	AUDION THERAPEUTICS BV Organization address address: LINNAEUSPARKWEG 10-2 city: AMSTERDAM postcode: 1098 EA website: www.audiontherapeutics.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Netherlands [NL]
Project website	http://yourhearing.eu
Total cost	5˙834˙340 €
EC max contribution	5˙834˙340 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-PHC-2014-two-stage
Funding Scheme	RIA
Starting year	2015
Duration (year-month-day)	from 2015-05-01 to 2019-10-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	AUDION THERAPEUTICS BV AUDION THERAPEUTICS BV Organization address address: LINNAEUSPARKWEG 10-2 city: AMSTERDAM postcode: 1098 EA website: www.audiontherapeutics.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (AMSTERDAM)	coordinator	1˙821˙330.00
2	Eli Lilly and Company Limited Eli Lilly and Company Limited Organization address address: Lilly House, Priestley Road city: Basingstoke postcode: RG24 9NL website: www.lilly.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (Basingstoke)	participant	1˙347˙362.00
3	UNIVERSITY COLLEGE LONDON UNIVERSITY COLLEGE LONDON Organization address address: GOWER STREET city: LONDON postcode: WC1E 6BT website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	1˙051˙188.00
4	NORDIC BIOSCIENCE CLINICAL DEVELOPMENT A/S NORDIC BIOSCIENCE CLINICAL DEVELOPMENT A/S Organization address address: HERLEV HOVEDGADE 207 city: HERLEV postcode: 2730 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (HERLEV)	participant	715˙818.00
5	EBERHARD KARLS UNIVERSITAET TUEBINGEN EBERHARD KARLS UNIVERSITAET TUEBINGEN Organization address address: GESCHWISTER-SCHOLL-PLATZ city: TUEBINGEN postcode: 72074 website: www.uni-tuebingen.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (TUEBINGEN)	participant	331˙250.00
6	ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON Organization address address: 6 CHRISTOU LADA STR city: ATHINA postcode: 10561 website: www.elke.uoa.gr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (ATHINA)	participant	287˙466.00
7	UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST Organization address address: EUSTON ROAD 250 city: LONDON postcode: NW1 2PG website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	153˙151.00
8	TTOPSTART BV TTOPSTART BV Organization address address: EUCLIDESLAAN 1 city: UTRECHT postcode: 3584 BL website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	125˙000.00
9	ACCELOVANCE EUROPE BV ACCELOVANCE EUROPE BV Organization address address: VICTORIALAAN 15 city: 'S-HERTOGENBOSCH postcode: 5213 JG website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL ('S-HERTOGENBOSCH)	participant	1˙771.00

Map

Project 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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