A clinical trial will test the efficacy of the treatment IMCY-0098 in patients with recent onset Type 1 Diabetes.
Imcyse, a clinical-stage biopharmaceutical company pioneering the development of a new class of active and specific immunotherapies for the treatment of severe autoimmune diseases, recently announced the first patients’ treatment in the IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT) study with IMCY-0098.
The IMPACT Study is a multi-centre, randomised, double-blind, placebo-controlled study in newly diagnosed Type 1 Diabetes patients. Study sites will be located across Europe, with around 13 sites in Belgium, Sweden, Slovenia, Italy, and the UK.
The IMPACT trial, in collaboration with INNODIA, will evaluate the ability of the Imotope IMCY-0098 to preserve beta-cell function in adult and adolescent patients with recent onset Type 1 Diabetes, as well as determining the best and safest dose and regimen for continued development.
Developing treatment for Type 1 Diabetes
IMCY-0098 is the most advanced Imotope in development and is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta-cells. With early intervention, the aim is to preserve the pancreas’ ability to produce insulin and allow patients to manage the disease without the need for daily insulin injections. The Imcyse approach is unique and distinct to general tolerance induction or overall “immune-suppression”.
Imotopes specifically target the autoimmune pathway without harming the rest of the immune system. In the first-in-human EXALT trial, IMCY-0098 was found to be safe and well tolerated at all doses tested. Initial trends of clinical and immunological benefits were also observed.
Denis Bedoret, Imcyse CEO, said: “Imcyse is developing a new approach to treating Type 1 Diabetes, which seeks to intervene early enough in the disease progression to preserve pancreatic function by specifically targeting the autoreactive immune cells. Our Imotope technology has great potential to result in a cure for patients suffering from this and other life altering autoimmune diseases.”
The first step of the study will enroll 24 participants, aged 18 – 45 and diagnosed within nine weeks (date of first insulin injection), who are randomly assigned to one of three treatment arms and will follow patients for up to 48 weeks. This step will explore the immune signature and the safety of the treatment comparing two different doses with placebo. Results from these findings will be used to determine the best dose and regimen for IMCY-0098 to be used in the second step.
The second step will see 60 participants, both adults between 18 – 45 years and adolescents aged 12 – 17 recruited to evaluate the treatment effect on the preservation of beta-cell function.
Expert in the field of Type 1 Diabetes and co-ordinator of INNODIA (the largest European Type 1 Diabetes network), Professor (Dr) Chantal Mathieu, said: “INNODIA is privileged to collaborate with Imcyse on the IMPACT programme to progress the development of the Imotope which is a very interesting and different approach to preserve beta-cells. Together we have been able to design a clinical trial that will truly benefit patients by determining the most appropriate and safe dose to test the drug for efficacy in recently diagnosed Type 1 Diabetes patients.”
Patient recruitment is ongoing and topline data from the study is anticipated in the second half of 2023.