In Type 1 diabetes (T1D), the insulin-producing beta cells in the pancreas are destroyed through an autoimmune attack. The loss of beta cells leads to insulin insufficiency and hyperglycemia, with patients eventually requiring lifelong insulin therapy to maintain normal glycemic control.
For the majority of the approximately 9 million juveniles and adults affected worldwide, living with T1D means burdensome round-the-clock self-management including a strict diet, frequent monitoring of blood glucose levels along with lifelong daily insulin injections. But even with modern technologies, controlling blood glucose levels to a level that will eliminate immediate risks, such as hyperglycaemia or hypoglycaemia and serious long-term complications such as organ damage caused by high-blood sugar remains unachievable for most patients.
Despite its global impact and improvements in disease management, there is still no cure for T1D, leaving an urgent need for new advances that can reduce the number or replace daily insulin injections and obtain better overall control.
IMCY-0098, a synthetic peptide based on insulin (one of the proteins to which the body begins to mount an aberrant immune response) is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta cells. With early intervention, the pancreas’ ability to produce insulin may be preserved, enabling patients to manage the disease with minimal insulin injections and hopefully in some cases without the need for insulin at all.
In a Phase 1b study with 41 newly diagnosed patients, IMCY-0098, was found to be safe and well tolerated, with steady levels of C-peptides detected in some T1D patients up to 6 months following treatment, providing an encouraging signal for the Imotope™ platform. The T1D program was conducted by a European consortium (EXALT) and supported by a European grant of the 7th framework program. Results of the Phase 1b clinical trial were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2019.
IMCY-0098 is currently being investigated in a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study in patients with recent onset T1D. The IMCY-0098 Proof of Action in Type 1 Diabetes (IMPACT) clinical trial, conducted in collaboration with INNODIA, the largest European T1D network, is evaluating the preservation of beta cell function in patients treated with IMCY-0098.
The study completed recruitment in March 2023 exceeding its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Efficacy proof-of-concept data from IMPACT is expected in Q1 2024.
Positive biomarker data, reported in January 2022, from a planned interim analysis conducted by Professor Tim Tree, Ph.D, Department of Immunobiology, King’s College London showed that IMCY-0098 treatment induces an insulin-specific cytolytic CD4+ immune signature, concomitant with prevention of the expansion of insulin-specific pathogenic Th17 T-cells. A promising preliminary result adding to the growing body of evidence supporting the ImotopeTM platform.
The IMPACT clinical trial is supported by the Walloon Region of Belgium under the grant agreement N 8234.
To learn more about T1D and the IMPACT trial visit: https://clinicaltrials.gov/ct2/show/NCT04524949, INNODIA and T1D UK Consortium.