Imcyse to present first-in-human phase 1b study results in type 1 diabetes at EASD 2019

Company's insulin-based Imotope(TM) IMCY-0098 shows excellent safety profile and promising clinical trends

Liège, Belgium, September 18, 2019 - Imcyse, a clinical-stage company developing active and specific immunotherapeutics for the treatment and prevention of severe chronic diseases, today announces the presentation of the results of its first clinical trial in patients with early type 1 diabetes. The company will present a poster and host a dedicated symposium during the (European Association for the Study of Diabetes) that takes place in Barcelona from 16 to 20 September.

Results of the clinical trial have shown an excellent safety profile, reaching the primary study objective. For the very first time, Imotope-induced cytolytic CD4 T-cells were detected in humans, along with a concomitant decrease of effector T-cells involved in the disease, which fully supports the mechanism of action previously described in animal models. In addition, promising early clinical trends towards better outcomes in higher dose cohorts were detected and shown to be linked to these immunological responses.

The poster (P732) will be presented by Dr Jean Van Rampelbergh on September 18, during Poster Event D on new avenues in diabetes treatment from 1:15pm to 2:15pm CEST.

The double-blind, placebo-controlled, dose-escalation (three dose groups) study enrolled 41 adult patients with insulin-dependent type 1 diabetes diagnosed within six months prior to inclusion. It took place in seven European countries: Belgium, Denmark, France, Germany, Lithuania, Sweden and the UK. After four subcutaneous injections of IMCY-0098 at zero, two, four and six weeks, clinical and immunological read-outs were recorded at different points in time, up to a period of six months. A long-term follow-up of up to 12 months will be completed at the end of 2019.

"These results provide us with the confidence to take the appropriate steps to advance IMCY-0098 into its next phase of clinical development and to implement our plans for additional projects in autoimmune diseases with major unmet medical needs," said Thomas Taapken, executive chairman of Imcyse. "The confirmation of the mode of action for our lead project also paves the way for collaboration projects with pharmaceutical and biotech companies interested to jointly explore our technology in other disease areas."

Imcyse's unique technology platform is based on specifically modified peptides (Imotopes(TM)) that drive the generation of cytolytic CD4 T-cells. These cytolytic CD4 T-cells are able to actively and specifically target the immune cells involved in the pathogenesis of the respective autoimmune disease. The potential to disrupt undesirable autoimmune responses that drive the process of destruction of the insulin producing beta cells in the pancreas, and to stop disease progression in T1D, can be achieved with this therapy. IMCY-0098 is the lead candidate in the company's research portfolio.

The trial received European funding under the EXALT program supported by the European Union's Seventh Framework Program and the Walloon Region (DGO6).

About Imcyse
Imcyse develops active targeted immunotherapies to treat and prevent severe chronic diseases caused by disruptions of the immune system. The company's unique active immunotherapy 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(TM), which are specifically modified peptides, allowing for the generation of cytolytic CD4 T-cells. 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 in seven European countries. Beyond type 1 diabetes, Imcyse is developing a pipeline of Imotopes(TM) for the treatment of several autoimmune diseases. Based in Liège, Belgium, Imcyse was originally founded in 2010 as a spin-off from the KU Leuven, Belgium.

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