DGAP-News: Imcyse SA
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Imcyse Reports Positive Immune Response from Interim Analysis of Phase 2 IMPACT Type 1 Diabetes Study
Liège, Belgium, January 13, 2022 - 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.
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13.01.2022 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.