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

Descripción del proyecto

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Tratamientos innovadores contra la diabetes de tipo 1

La diabetes de tipo 1 (DM1) es una enfermedad autoinmunitaria asociada con la destrucción de las células β del islote de Langerhans, lo que lleva a una producción deficiente o nula de insulina. El proyecto INNODIA HARVEST, financiado con fondos europeos, es llevado a cabo por una amplia red de expertos que tienen como objetivo prevenir o detener la DM1 mediante estrategias innovadoras. El proyecto tiene su origen y se basa en el consorcio INNODIA. Los socios realizarán una serie de ensayos de intervención para estudiar los mecanismos de la DM1, identificar los biomarcadores y estudiar las vías asociadas a la patología de la enfermedad. A través de un ensayo de intervención centrado en las células β y otro centrado en el sistema inmunitario, el equipo espera aportar conocimientos fundamentales para nuevas politerapias y nuevos posibles fármacos para futuros tratamientos de la DM1. El equipo del proyecto INNODIA HARVEST se preocupa por las personas que padecen esta enfermedad y, por ello, impulsará la aplicación de resultados centrados en el paciente, conformará ensayos clínicos y mejorará sustancialmente la consideración de la DM1.

Objetivo

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.

Ámbito científico

Palabras clave

Programa(s)

Tema(s)

Convocatoria de propuestas

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

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Régimen de financiación

RIA - Research and Innovation action

Coordinador

KATHOLIEKE UNIVERSITEIT LEUVEN
Aportación neta de la UEn
€ 641 502,50
Dirección
OUDE MARKT 13
3000 Leuven
Bélgica

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Región
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Tipo de actividad
Higher or Secondary Education Establishments
Enlaces
Coste total
€ 1 645 007,56

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Última actualización: 8 Octubre 2024

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

European Union, 2024