Liège, Belgium, November 5, 2018 – Imcyse, who develop active specific immunotherapies for the treatment and prevention of severe chronic diseases, today announces the successful enrolment of 41 patients with recent-onset type 1 diabetes into its first-in-human Phase 1b study.
The double-blind, placebo-controlled, dose-escalation clinical study recruited patients with insulin-dependent type 1 diabetes diagnosed within six months prior to inclusion, from seven European countries (Belgium, Denmark, France, Germany, Lithuania, Sweden and the UK). The trial investigates the safety, the immunological responses and the clinical impact of Imcyse’s unique Imotopes™ technology. An independent data safety monitoring committee review has rated the safety profile so far as excellent. Complete results are expected in summer 2019.
Imcyse’s novel Imotopes technology leads to the active and specific elimination of the immune cells involved in the destruction of the insulin-producing beta cells in the pancreas. Treatment with a specific Imotope therefore has the potential to disrupt the undesirable immune response that drives the process of destruction of the pancreas and to stop disease progression.
Preclinical studies showed a potent and sustained effect after just a few subcutaneous injections.
“We are delighted by the successful enrollment in our first-in-human trial for Imcyse’s Imotope
technology,” said Pierre Vandepapelière, CEO of Imcyse. “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.”
The incidence of type 1 diabetes is rapidly increasing in high-income countries at an annual rate of about 3 per cent, 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 trial received European funding under the EXALT program supported by the European Union’s Seventh Framework Program and from the Walloon Region (DGO6).
Further details on the clinical study can be found here.
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 destroy locally the immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes™, which are specific modified peptides, allowing for the generation of a new type of T-cell, called cytolytic CD4. Imcyse’s approach, sustained over time, helps to prevent and treat diseases with no current therapeutic alternative and to cure the patient without impairing immune defenses.
The company has established proof of concept and has launched its first clinical trial in type 1 diabetes in seven European countries.
Other projects, which address multiple sclerosis and rheumatoid arthritis, are at preclinical and proof-of-concept research stages, respectively.
Founded in 2010, Imcyse is a spin-off from the Katholieke Universiteit Leuven (KUL), Belgium. The company is based near the Belgian city of Liège. It is managed by a small group of pharmaceutical industry experts.