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Translational approaches to disease modifying therapy of type 1 diabetes - HARVESTing the fruits of INNODIA

Descrizione del progetto

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Verso terapie innovative contro il diabete di tipo 1

Il diabete di tipo 1 (T1D) è un disturbo autoimmune associato alla distruzione delle cellule beta delle isole pancreatiche, che porta a una produzione di insulina insufficiente o addirittura assente. Il progetto INNODIA HARVEST, finanziato dall’UE, è l’iniziativa di una vasta rete di esperti che mirano a prevenire o ad arrestare il T1D attraverso strategie innovative. Il progetto si basa sulle solide basi del consorzio INNODIA, la sua origine. I partner eseguiranno una serie di sperimentazioni di intervento per studiare i meccanismi del T1D, identificare i biomarcatori e studiare i percorsi associati alla patobiologia della malattia. Attraverso una sperimentazione di intervento focalizzata sulle cellule beta e sul sistema immunitario, il team spera di fornire conoscenze di rilievo per nuove terapie di combinazione e di stabilire canali di ricerca per le future terapie per il T1D. Le persone affette da T1D restano al centro di INNODIA HARVEST, guidando l’implementazione dei risultati incentrati sul paziente, modellando le nostre sperimentazioni cliniche e apportando cambiamenti significativi nella prospettiva della malattia.

Obiettivo

Building on the strong foundations of INNODIA, with its unique, Europe-wide clinical and basic research network for the study of type 1 diabetes (T1D), we propose in INNODIA HARVEST an ambitious program which aims to prevent and arrest T1D via focused objectives targeting consolidation and innovation. First, we will consolidate the INNODIA clinical network as the reference point for conducting studies to prevent or arrest T1D. We will transform our standardized clinical and bioresource platforms into a high-performance clinical trial network, running academic and industry-driven trials alongside small, mechanism-centric, biomarker-rich intervention trials to examine pathobiological pathways to T1D. INNODIA HARVEST will conduct two large studies to arrest T1D at its onset, one academia-driven, beta-cell focused (VER-A-T1D, verapamil) and one industry-driven, immune-focused (Iscalimab-study). We will exploit our original INNODIA Master Protocol allowing novel adaptive trial design to introduce combination therapies that build on complementary mechanisms. Second, we will extend our study design strategy by introducing novel biomarkers, both clinical (continuous glucose monitoring) and experimental (microbiome analysis) to deconvolute disease heterogeneity and identify new endpoints to accelerate identification of effective therapeutics. Third, we will use ‘disruptors’ in small mechanistic studies to channel innovation from clinic to basic research through a reverse immunology and reverse beta-cell biology approach. Finally, we will implement new discovery pipelines for future therapeutics, exploiting tools such as iPSC-derived islet-like cells to promote next generation target identification and drug development. As in INNODIA, the voice of people living with T1D and their families will hold a central place in INNODIA HARVEST to drive implementation of new, patient-proximal outcomes, shape our clinical trials, and bring about a meaningful change in disease perspective.
A major objective of INNODIA Harvest is the execution of at least two new phase 2 trials (studying Verapamil (VER-A-T1D) or Iscalimab (CCFZ533X2207)). Considering the expected time to first patient-in as preparations for trial start can only be initiated after the start of the Action and possible fluctuating recruiting rates, due to the intercurrent COVID epidemic, there is a risk that INNODIA HARVEST will not be able to completely finalize the clinical trials, fully analyse the biomarkers collected and publish the results in the initially proposed 24 months duration. To ensure the finalization of the clinical trials and corresponding full execution of the given budget including eligibility of EFPIA in-kind contribution we propose to extend the duration of the Action from 24 to 36 months.

Campo scientifico

Parole chiave

Programma(i)

Argomento(i)

Invito a presentare proposte

H2020-JTI-IMI2-2019-19-single-stage

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Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

KATHOLIEKE UNIVERSITEIT LEUVEN
Contribution nette de l'UE
€ 641 502,50
Indirizzo
OUDE MARKT 13
3000 Leuven
Belgio

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Regione
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 1 645 007,56

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Ultimo aggiornamento: 8 Ottobre 2024

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Permalink: https://cordis.europa.eu/project/id/945268/it

European Union, 2024