Imcyse has completed patient enrolment in its first-in-human Phase Ib clinical trial to examine the safety, immunological responses and clinical impact of Imotopes for the treatment of type 1 diabetes.
Type 1 diabetes is currently estimated to affect more than 40 million people worldwide and the disease is growing in high-income countries at an annual rate of nearly 3%.
The double-blind, placebo-controlled, dose-escalation trial has enrolled 41 patients with insulin-dependent type 1 diabetes diagnosed six months or later before recruitment.
Patients were enrolled from seven countries in Europe, which are Belgium, Denmark, France, Germany, Lithuania, Sweden, and the UK.
The trial’s primary outcome measure is the incidence of all adverse events among patients for up to 24 weeks.
The trial’s secondary endpoint includes evaluation of residual beta cell function and markers of metabolic control for up to a 24 week period.
Complete results from the trial are expected to be available next year.
Walloon Region (DGO6) and EU’s Seventh Framework Programme, through the EXALT initiative, have provided funding for the trial.
Imcyse CEO Pierre Vandepapelière said: “This trial will provide us with essential insight in how our technology works in humans.
“This will support the ongoing development of Imotopes for other autoimmune diseases, such as multiple sclerosis.”
Imotopes are modified peptides designed to facilitate the active and specific elimination of cells involved in the destruction of the insulin-producing beta cells in the pancreas.
Various preclinical studies have demonstrated a sustained impact of Imotopes following a few subcutaneous injections.