KU Leuven Spinoff Investigational Drug for Diabetes Shows Promise in Phase I Clinical Trial

Sep 1, 2019 | Autoimmune Disease, Hôpital Cochin, KU Leuven, Type 1 Diabetes

Closeup view of blood test equipment for diabet

Belgium-biotech Imcyse is developing IMCY-0098, spinoff intellectual property developed at KU Leuven. A recent Phase I trial enrolled 41 patients newly diagnosed with type 1 diabetes. The investigational drug not only met its endpoint safely but also revealed additional benefits such as lowering the number of autoimmune cells in the participant’s blood.

The Study

The study was designed to evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. The sponsor offered three doses of the investigational product that was tested in successive cohorts. Although safety was the first objective of Phase I clinical trial, the sponsor sought to gather efficacy data and perform a set of immunological tests to better understand the mechanism of action of this new approach in young adults with recent onset of type 1 diabetes.

Phase I clinical investigational sites were set up across Europe in Belgium, Denmark, France, Germany, Sweden, and the UK. The Principal Investigator for this Phase I study was Christian Boitard, MD of Hôpital Cochin, Paris, France.

The Results

The trial revealed no major health problems from the treatment as the sponsor met the targeted endpoint. Moreover, the drug showed signs of additional benefit—reducing the autoimmune cells in patient’s blood reported Jonathan Smith with Labtech.eu.

Imcyse CEO on the results was quoted in Labtech.eu “We all feel very excited” and “The study was designed to yield much more than safety results and we now have a clear demonstration of the potential of Imcyse technology for the treatment of type 1 diabetes at its onset.”

IMCY-0098: the Investigational Product

As type 1 diabetes is an autoimmune condition triggered by immune T cells acting out of control and essentially killing insulin-producing cells in the pancreas, Imcyse, leveraging research developed at KU Leuven, is “developing peptides that prime cells called cytolytic T cells to watch out for and kill the autoimmune cells without harming other parts of the immune system” as reported in Labtech.eu. In the case of IMCY-0098 investigators believe it will work best with recently diagnosed patients as they still have insulin-producing cells to save.

Moving Forward

Imcyse will plan on Phase II clinical trial early in 2020 given the success of the Phase I study. Earlier this year the Belgium venture raised €35 million in a Series B round to fund the development of this drug in type 1 diabetes as well as a Phase I trial of its drug to treat the neurological autoimmune disease multiple sclerosis in 2020.

Lead Research/Investigator

Christian Boitard, MD of Hôpital Cochin, Paris, France

Call to Action: It would appear that Imcyse is on to something promising with IMCY-0098. TrialSite News will continue to monitor the Phase II study for type 2 diabetes. The lead investigator, Christian Boitard, could be a good contact for those interested in monitoring this research. Dr. Boitard’s email: Christian.boitard@cch.aphp.fr

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