A new European multi-stakeholder partnership – INNODIA – has been launched to advance understanding of type 1 diabetes and develop tools and technologies that will allow health professionals to predict, evaluate and prevent the onset and progression of the condition. For people living with type 1 diabetes, this would mean the ability to predict the rate at which their condition will progress. The knowledge and tools generated by INNODIA will help researchers to optimize the design of clinical trials for treatments that will hopefully prevent and cure this potentially debilitating condition that affects around 10% of people living with diabetes.
INNODIA is a consortium of 40 European partners funded by the European Commission. It brings together a large team of international academic researchers and the most important pharmaceutical companies active in diabetes research.
The needs and concerns of people with type 1 diabetes are at the heart of INNODIA. A Patient Advisory Committee (PAC) has been set up to give a voice to the experiences and desires of people living with type 1 diabetes and their family members. This is intended to ensure close alignment with the goals and strategy of INNODIA and that the specific outcomes of the project have the potential to improve the lives of people affected. The PAC consists of of nine people with type 1 diabetes or close family members of people with the condition, from throughout the European Union.
A key focus of INNODIA is conducting clinical intervention studies to facilitate the development of novel treatments to prevent and cure type 1 diabetes. The Innovative Medicines Initiative (IMI) of the European Commission has approved an additional section of work on biomarkers and prevention of type 1 diabetes within INNODIA. This additional section is called ‘INNODIA HARVEST’, and is aimed at ‘harvesting’ the findings that have already arisen from the project.
One study is currently recruiting children and adults across Europe between the ages of one and 45, who have been diagnosed with type 1 diabetes within the previous six weeks. First-degree family members (brothers, sisters, parents or children) of these people can also participate to investigate if they have an increased risk of developing the condition. INNODIA has established a network of clinical centers throughout Europe, where participants will be invited for five hospital visits over a two-year period. The study consists of an initial screening for the presence of auto-antibodies in family members. These auto-antibodies are markers of some degree of activity of the immune system against insulin-producing beta cells. By investigating blood, urine and stool samples of participants, it is hoped to discover biomarkers to predict and possibly avoid developing type 1 diabetes through new therapies.
The following trials will start before the end of 2020 with the hope of slowing down the decline of beta cells to protect insulin production.
- MELD-ATG: The drug ATG (Anti Thymocyte Globulin) provided by INNODIA partner Sanofi, will be tested over 12 months in children and adults. ATG is a drug recently shown to be able to keep a balance between attacking and regulating cells within the immune system, thereby helping to preserve insulin secretion. One aim of the study is to define the minimal effective dose of ATG treatment.
- VER-A-T1D: A study involving Verapamil, a known blood pressure lowering drug that has been shown to protect and strengthen beta cells, slowing down beta cell destruction in people with type 1 diabetes.
- CFZ533 (ISCALIMAB): A study in collaboration with Novartis involving the drug Iscalimab, which has also been shown to slow down the destruction of beta cells. The study will initially be conducted on people with newly diagnosed type 1 diabetes between the ages of 15 and 25. If proven safe, younger people will also be included in a second phase.
- IMPACT: This trial will investigate a very specific and novel immunotherapy called Imotopes™, which has the potential to stop the progression of type 1 diabetes. This treatment is still in its early phase of development but was proven safe in a first clinical trial. The study will initially evaluate two doses. When the right dosage has been defined, adolescents aged between 12 and 17 will be enrolled to evaluate its efficacy on preventing the destruction of beta cells.
For more information about INNODIA, visit www.innodia.eu.
