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

Description du projet

Vers des thérapies innovantes contre le diabète de type 1

Le diabète de type 1 (T1D) est une maladie auto-immune associée à la destruction des cellules bêta des îlots pancréatiques, entraînant une production faible ou nulle d’insuline. Le projet INNODIA HARVEST, financé par l’UE, est mené par un important réseau d’experts qui visent à prévenir ou à enrayer le T1D au moyen de stratégies innovantes. Le projet s’appuie sur les bases solides du consortium INNODIA, son précurseur. Les partenaires réaliseront une série d’essais d’intervention pour étudier les mécanismes du T1D, identifier ses biomarqueurs et étudier les voies associées à la pathobiologie de la maladie. Par le biais d’un essai d’intervention axé sur les cellules bêta et d’un essai d’intervention axé sur le système immunitaire, l’équipe espère apporter des connaissances clés pour de nouvelles thérapies combinées et établir des filières de découverte pour les futures thérapies pour soigner le T1D. Les personnes atteintes de T1D restent au centre d’INNODIA HARVEST, encourageant la mise en œuvre de résultats centrés sur les patients, façonnant nos essais cliniques et apportant un changement significatif dans la perspective de la maladie.

Objectif

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.

Coordinateur

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

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Région
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Type d’activité
Higher or Secondary Education Establishments
Liens
Coût total
€ 1 888 612,06

Participants (40)