INNODIA is ready for a new phase - clinical trials
From start on, a major goal of INNODIA was to undertake clinical intervention studies and to pave the way for the development of novel treatments to prevent and cure Type 1 Diabetes.
INNODIA is now performing mechanistic-based clinical studies, using a Master-Protocol established within INNODIA.
People with newly diagnosed Type 1 Diabetes can take part in research that aims to generate knowledge helping to arrest further disease development. Type 1 diabetes is an autoimmune disease in which immune cells of the body attack specifically the insulin producing beta cells in the pancreas, leading to their steady decline. Decrease in functional beta cell mass leads to loss of blood glucose control. Regaining blood glucose control via multiple daily insulin injections is challenging and often insufficient leading to the development of numerous complications.
With the clinical intervention trials to be conducted within INNODIA, the goal is to halt the further decline in beta cell functionality in people with newly diagnosed T1D addressing the immune system or the beta cells by different treatment modalities.
When someone is first diagnosed with T1D, half of the pancreatic insulin producing beta cells are still working. The beta cells have not yet been all destroyed. Therefore, newly diagnosed people still produce some of their own insulin. Two INNODIA clinical trials, aim to stop the bodys immune attack from further destroying their beta cells in newly diagnosed people with T1D. If successful, preservation of the bodys own insulin production capacity will improve the blood glucose control of the participants. In a third trial, the treatment aims to stabilize/strengthen directly the bodys insulin producing beta cells.
The participants are people that have been newly diagnosed with T1D within a 6 weeks window. Treatment start at this early time of diagnoses implies the highest benefit on preserved insulin producing beta cells.
The dream ultimately is to halt further disease progression!
The drug ATG (Anti Thymocyte Globulin) provided by our partner Sanofi, will be tested over 12 months in children to adults (5 to 25 years, n=114). ATG, given once in a two days infusion regimen, is a drug recently shown to be able to keep the balance between attacking and regulating cells within the immune system, and thereby helping to preserve insulin secretion. Defining the minimal effective dose of ATG treatment is one aim of the study.
The IMPACT trial will investigate a very specific and novel immunotherapy called Imotopes™ that has the potential to stop the progression of type 1 diabetes. The treatment is still in its early phase of development but was proven safe in a first clinical trial. The study will first evaluate two doses in newly diagnosed adult (18-45 years) patients. When the right dosage has been defined, adolescents between 12 and 17 years will also be enrolled to evaluate efficacy on stopping the loss of the beta cell. Participants will receive up to 6 injections and will be followed for 1 year.
A second INNODIA trial starting soon is a study with Verapamil. This known blood pressure lowering drug has been shown recently to protect and strengthen beta cells and slowing down beta cell destruction in T1D. The trial will include 120 patients aged between 18 and 45 years, taking tablets for 1 year.
About the Trial
The VeR-A-T1D is a randomized, double blind, placebo controlled, parallel group, multi-center trial. The study will try to establish the effect of a drug used to control high blood pressure in stopping the decline of beta-cells. The drug Verapamil will be given orally in sustained release form once a day to participants aged between 18 and 45 who have been diagnosed over the last 6 weeks.
A third trial planned in the upcoming months is a study in collaboration with Novartis. The drug called Iscalimab has also been shown to slow down the loss of the beta cells. The study will be performed on people with newly diagnosed Type 1 diabetes between 15 and 25 years to start with. If proven safe, younger patients will also be enrolled in a second phase. In this trial people will be given one infusion, followed by weekly injections for 1 year.
About the Trial
INNODIA is now collaborating with Novartis Pharmaceuticals on a study to evaluate the safety of the investigational drug CFZ533 (Iscalimab) in young adult and pediatric patients with recent onset type 1 diabetes. The study will also evaluate whether CFZ533 can protect the remaining pancreatic beta cells. The study is now ongoing in Belgium, and will be opening in other European countries soon.
A clear priority of INNODIA is to keep the needs and concerns of people living with Type 1 Diabetes at the center of the project. Therefore, INNODIA has a very active and dedicated Patient Advisory Committee (PAC).
Especially when it comes to clinical trials, the role of the PAC becomes most important. People with T1D and their relatives need a strong voice! Their advice and experiences helps the discussion of how the trials should be designed - What do we ask people to do - How do we explain things to the participants - Which collaterals should we use - Are we measuring the things that matter to people (hypo glycaemia, the effort spent on diabetes, satisfactions, challenges, difficulties …?)