Imcyse Announces Completion of Enrollment in Phase 2 IMPACT Trial of IMCY-0098 for Type 1 Diabetes

• Exceeded target enrollment with 110 patients randomized across 28 clinical sites in Europe, the United States and Australia
• Efficacy proof-of-concept data from IMPACT is expected in Q1 2024. Following the positive interim biomarker analysis reported earlier last year, these data results will inform final Phase 3 protocol design while also further supporting IMCY-0098 and our Imotope™ mode of action
• Critical unmet need remains for effective prevention strategies or curative therapies in Type 1 diabetes beyond insulin replacement that can delay disease onset or arrest progression and improve patient quality of life

Liège, Belgium, March 1, 2023 – 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, today announced completion of patient enrollment in its Phase 2 IMPACT (IMCY-0098 Proof of ACtion in Type 1 Diabetes) trial of its lead product candidate IMCY-0098, a proinsulin-derived Imotope™ engineered to halt the progression and prevent early-onset Type 1 diabetes (T1D). 

“Reaching the enrollment target is a key milestone in our effort to advance IMCY-0098 as a disease-modifying treatment and clinical proof of concept for the Imotope™ platform,” said Denis Bedoret, CEO of Imcyse. “Imcyse has made significant strides in the past year evolving into a clinical-stage company, with two candidates now in clinical development and other programs advancing towards the clinic. We are encouraged by the strength of our IMCY-0098 data to date, including our Phase 1 EXALT study and the IMPACT biomarker interim analysis, and we look forward to reporting topline IMPACT results in the first quarter of 2024.”

Jean Van Rampelbergh, CCDO of Imcyse added: “The potential of Imotopes™ to not only slow but also halt disease progression represents an innovative therapeutic approach that could transform the T1D treatment landscape. The successful recruitment of IMPACT has been the result of a fantastic collaboration with our partners, and we would like to thank INNODIA, T1D UK, as well as all clinical trial physicians and staff, including in Australia, Lithuania and the US, for their dedication to this program.”

IMPACT is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study designed to evaluate proof of concept efficacy of IMCY-0098 in adults with newly diagnosed T1D. The study is conducted in collaboration with INNODIA, the largest European T1D network comprised of 40 members, including academic institutions, industrial partners and patient organizations. The study exceeded its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Patients are randomized 1:1:1 to receive multiple doses plus a booster of 450 μg IMCY-0098, 1350 μg IMCY-0098 or placebo. The primary endpoint is the change from baseline in C-peptide level. Secondary endpoints include hemoglobin A1C levels, insulin use and continuous glucose monitoring. In addition, biomarker analysis will characterize the immune signature induced by IMCY-0098. Topline results are expected in the first quarter of 2024, based on the 48-week follow up period built into the study. 

Data from a previously reported interim biomarker analysis of the Phase 2 IMPACT study 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. In addition, IMCY-0098 demonstrated a favorable safety and tolerability profile in the Phase 1 EXALT trial, with no statistically significant difference in adverse events between placebo group and treated group. Results from the Phase 2 IMPACT trial are expected to inform the design of a Phase 3 trial.

“Type 1 diabetes is a debilitating, lifelong disease linked to a multitude of other problems that impact overall health. There remains a critical unmet need for effective prevention strategies or causal therapies beyond insulin replacement that can improve patient quality of life,” commented Prof. Dr. Chantal Mathieu Principal Investigator of the IMPACT study and Coordinator at T1D consortium INNODIA. “Imcyse’s immunotherapy approach is very promising as it targets the underlying cause of the disease by reprogramming the immune system so that it no longer attacks and destroys insulin-producing beta cells in the pancreas. I am delighted to see that recruitment in the Phase 2 trial is now complete, and I look forward to the further development of this promising candidate.”

The IMPACT clinical trial is supported by the Walloon Region of Belgium under grant agreement N° 8234.

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ABOUT TYPE 1 DIABETES

In T1D, beta-cells in the pancreas are destroyed due to an improper immune response. This damage to the pancreas causes the organ to stop producing insulin, the hormone that controls blood-sugar levels. In most cases, the onset of T1D occurs in children and adolescents, but it can also affect adults.

ABOUT IMCY-0098

IMCY-0098, the Company’s most advanced Imotope™ in development, 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.

ABOUT IMCYSE

Imcyse is a clinical stage biopharmaceutical company pioneering the development of a new class of active specific immunotherapies for the treatment of severe chronic autoimmune diseases. The company’s unique technology platform allows it to locally target immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes™, which are synthetic peptides encompassing a T cell epitope and an active thioredox motif. , Imotopes™ generate cytolytic CD4 T-cells that specifically eliminate autoantigen-presenting cells and autoantigen-specific lymphocytes involved in the disease pathways. Imcyse’s approach, sustained over time, may help to prevent and treat diseases with no current therapeutic options and to potentially cure patients without impairing their immune defenses. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes with promising results and is expecting top-line data from the fully enrolled Phase 2 study in 2024. A clinical Phase 1/2 clinical trial in Multiple Sclerosis (MS) was initiated in April 2022. Beyond type 1 diabetes and MS, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases in large and rare disease indications. Imcyse was founded as a spin-off from the Catholic University of Leuven and is headquartered in Liège, Belgium.

ABOUT INNODIA

INNODIA, a consortium of 40 European partners funded by the European Commission, brings together a large team of international academic researchers and the most important pharmaceutical companies active in diabetes research. The project 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. INNODIA has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115797 (INNODIA) and No 945268 (INNODIA HARVEST) as part of the Horizon 2020 European program.

CONTACT:

Imcyse S.A.
Jean Van Rampelbergh
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