Imcyse's Phase 1b Clinical Trial in Type 1 Diabetes Begins Patient Enrolment Across Four European Countries

Imcyse, a biotechnology company developing active specific therapies for the treatment of severe chronic diseases, has announced that it began recruiting patients into its multicenter Phase 1b clinical trial in insulin-dependent (type 1) diabetes in September. The trial is now recruiting up to 40 patients at 15 clinical sites in four European countries (Belgium, Denmark, Germany and the United Kingdom) and should open soon in France.

Imcyse’s unique Imotopes™ are specific modified peptides that induce a unique type of T-cell. Known as cytotoxic T-cells, these actively and specifically kill immune cells involved in destroying the insulin-producing beta cells in the pancreas. Treatment with a specific Imotope has the potential to disrupt the undesirable immune response that drives the process of destruction of the pancreas. Preclinical studies showed a prolonged effect after just a few subcutaneous injections.

“We are delighted to have been the first to enroll a patient into Imcyse’s Phase 1b trial,” said Henrik Ullits Andersen, chief physician at the Steno Diabetes Center, Copenhagen (Denmark), cooperating closely with DanTrials ApS at Bispebjerg Hospital. “Imcyse’s technology is very promising as the Imotope therapy could be ideal for the treatment of patients with type 1 diabetes at very early stages. We are looking forward to recruiting further patients.”

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“Entering the clinical phase is a major milestone for a young biotechnology company like Imcyse,” said Pierre Vandepapelière, CEO of Imcyse. “We are very much looking forward to enrolling many more patients with recent onset type 1 diabetes into our first trial. We believe that our unique approach could bring a major breakthrough in addressing type 1 diabetes.”

The incidence of type 1 diabetes is rapidly increasing, with the disease increasingly occurring in younger children. It affects more than 40 million people worldwide. Currently, the only available treatment is to control the blood glucose level with multiple daily insulin injections.

The enrollment phase is expected to finish by the middle of 2018 with results expected at the end of 2018.

Imcyse’s Phase 1b trial received European funding under the EXALT program supported by the European Union’s Seventh Framework Program for Research and Technological Development.