Imcyse Reports Positive Immune Response from Interim Analysis of Phase 2 IMPACT Type 1 Diabetes Study

Positive interim biomarker data supports specific immune signature induced by IMCY-0098 and effect on potentially pathogenic T cells

Enrollment on track with half of patients dosed; recruitment scheduled to complete mid-year

IND accepted from U.S. FDA and Australia TGA for Phase 2 IMPACT Trial

LIÈGE, Belgium, Jan. 13, 2022 (GLOBE NEWSWIRE) --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 reported positive biomarker data from a planned interim analysis of its Phase 2 study, IMCY-0098 Proof of ACtion in Type 1 Diabetes (T1D) (IMPACT), evaluating the Company’s lead candidate IMCY-0098, a proinsulin-derived ImotopeTM engineered to treat and prevent T1D. The Company also reported that the study reached the midpoint of recruitment and both the U.S. Food and Drug Administration (FDA) and Australian Therapeutics Goods Administration (TGA) approved the Company’s Investigational New Drug (IND) application to initiate the study in these two countries.

In an exploratory analysis conducted by Professor Tim Tree, Ph.D, Department of Immunobiology, King’s College London, blood samples from 17 patients were analyzed. Data from ImotopeTM treated groups point to a number of findings, including: (1) the expansion of a population of CD4+ T cells expressing Granzyme B and anti-inflammatory markers similar to those observed previously. In addition, (2) no treatment-induced FOXP3+ regulatory T cells have been observed, which differentiates ImotopesTM from other antigen-specific immunotherapies, adding further evidence that ImotopesTM elicit their effect through a unique mechanism. Importantly, (3) in this initial analysis, ImotopeTM treatment, when compared to the placebo, prevented the expansion of a population of antigen-specific CD4+ T cells with pathogenic signature.

The U.S. FDA accepted Imcyse’s IND application for the Phase 2 IMPACT Trial. The TGA has also granted approval to initiate the trial in Australia. The Company plans to include U.S. and Australian clinical trial sites in the ongoing study, which has already reached the recruitment midpoint at European sites. The study is on track to complete recruitment by mid-year 2022, and Imcyse is preparing to initiate a trial in pediatric patients during 2H 2022.

“We are excited about the momentum we are building in the diabetes field as we execute on our goal of developing a new class of active and specific immunotherapies for the treatment of severe, chronic autoimmune diseases,” said Denis Bedoret, CEO of Imcyse. “Extending the study to U.S. and Australia allows us to bring IMCY-0098, a T1D therapeutic option with the potential to revolutionize the treatment for diabetes, to even more patients in need. The specific immune signature of our Imotopes and preventing the expansion of potentially pathogenic CD4+ T cells, as demonstrated in this recent analysis, is a promising preliminary result. This adds to the growing body of evidence supporting the ImotopeTM platform.”

The Phase 2 IMPACT clinical trial is a multicenter, randomized, double-blind, placebo-controlled, dose comparison study in patients with recent onset T1D. The study, conducted in collaboration with INNODIA, the largest European T1D network, evaluates the preservation of beta-cell function in patients who are treated with IMCY-0098. The Phase 1 trial demonstrated that IMCY-0098 produced a promising safety profile with steady levels of C-peptides detected in T1D patients up to 6 months following treatment, exemplifying proof-of-concept for the ImotopeTM platform and encouraging initial drug activity for patients with T1D.

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


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 modified peptides, allowing for the generation of cytolytic CD4 T-cells, that specifically eliminate antigen-presenting cells and autoantigen specific pathogenic lymphocytes. Imcyse’s approach, sustained over time, helps to prevent and treat diseases with no current therapeutic alternative and to potentially cure patients without impairing immune defense. The company has established proof of concept in several indications and has completed its first clinical trial in Type 1 Diabetes with promising results. Beyond type 1 diabetes, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases. Founded as a spin-off of the Catholic University of Leuven, Imcyse subsequently relocated to Liège, Belgium. 


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.


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