INNODIA HARVEST

INNODIA HARVEST built on the foundations laid by the previous IMI2 INNODIA project, and aimed at improving the understanding, treatment, and long-term outlook of people newly diagnosed with type 1 diabetes (T1D). The project strengthened and expanded the Europe-wide clinical network that was first established by INNODIA and carried out several clinical trials to test new potential therapies as well as exploring how T1D develops and identifying meaningful biomarkers. Throughout the project, people living with T1D and their families played an active role, ensuring that the research focused on outcomes that matter most to patients.

A central achievement was the development of an accredited network of 15 clinical trial centres across Europe and the UK. Through this network, three major clinical studies were conducted, each testing different approaches to slowing the loss of insulin-producing beta cells:

• Ver-A-T1D tested whether the drug verapamil could help preserve insulin-producing cells in adults newly diagnosed with T1D.
• Iscalimab (CFZ533) examined the safety and potential benefits of an immune-targeting therapy in children and young adults. The study showed iscalimab had an acceptable safety profile and the results indicate beneficial effects, although the study had a small sample size and had to be concluded earlier than planned.
• IMPACT evaluated a new immunotherapy called Imotopes™, which has the potential to halt the progression of type 1 diabetes. The treatment’s good safety profile had already been established in a previous clinical trial. The study is testing two doses of Imotopes™ in newly diagnosed adult patients to evaluate how well it can prevent beta-cell loss. 110 participants across 12 centres are enrolled in the trial, and results are expected to be published in due course.

In addition, the team developed a “master protocol” to streamline future trials, making it easier to test and compare multiple therapies more efficiently.

The project’s second major goal was to identify new biomarkers that can help understand T1D more precisely and speed up the development of effective treatments. This included analysing gut microbiome samples from people newly diagnosed with T1D and from those family members that are at a higher risk, as well as introducing continuous glucose monitoring into clinical trials. Standard procedures were created to help clinicians interpret these data consistently. Blood samples from the IMPACT trial were also analysed, and researchers are now linking these biomarker findings to clinical outcomes.

Beyond clinical work, the project supported fundamental research to uncover the biological mechanisms that drive T1D, leading to several high-impact scientific publications. Communication, visibility, and long-term sustainability were also key priorities. This led to the creation of INNODIA iVZW, a non-profit organisation designed to maintain the clinical trial network, support drug developers, facilitate new studies, and ensure strong involvement of people living with T1D.

Overall, INNODIA HARVEST significantly improved the research and clinical trial environment for T1D in Europe. It expanded access to innovative studies for patients, strengthened collaboration between scientists and clinicians, and created lasting structures to accelerate the development of new therapies. The project has offered renewed hope to people newly diagnosed with T1D and laid the groundwork for future progress in understanding, predicting, and eventually preventing the disease.