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

Projektbeschreibung

Auf dem Weg zu innovativen Therapien gegen Typ-1-Diabetes

Typ-1-Diabetes ist eine Autoimmunerkrankung, bei der die Beta-Inselzellen der Bauchspeicheldrüse zerstört werden, wodurch kein oder zu wenig Insulin produziert wird. Am EU-finanzierten Projekt INNODIA HARVEST ist ein Netzwerk von Fachleuten beteiligt, die Typ-1-Diabetes durch innovative Strategien verhindern oder aufhalten möchten. Das Projekt baut auf dem stabilen Fundament des INNODIA-Konsortiums auf, aus dem es hervorgeht. Die Partner werden eine Reihe von Interventionsstudien durchführen und so die Mechanismen des Typ-1-Diabetes untersuchen, Biomarker bestimmen und Aspekte näher betrachten, die mit der Pathobiologie der Erkrankung in Zusammenhang stehen. Anhand von Interventionsversuchen, die sich auf die Betazellen und auf das Immunsystems konzentrieren, möchte das Team wichtige Erkenntnisse für neue Kombinationstherapien liefern und neue Möglichkeiten für die Entdeckung künftiger Therapeutika gegen diesen Diabetes-Typ finden. Personen, die von Typ-1-Diabetes betroffen sind, stehen auch weiterhin im Mittelpunkt von INNODIA HARVEST. Sie treiben die Umsetzung patientenorientierter Ergebnisse an, prägen die klinischen Studien und bewirken eine sinnvolle Veränderung der Krankheitsperspektive.

Ziel

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.

Koordinator

KATHOLIEKE UNIVERSITEIT LEUVEN
Netto-EU-Beitrag
€ 641 502,50
Adresse
OUDE MARKT 13
3000 Leuven
Belgien

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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Aktivitätstyp
Higher or Secondary Education Establishments
Links
Gesamtkosten
€ 1 645 007,56

Beteiligte (41)