Type 1 Diabetes
Type 1 Diabetes (T1D) is an autoimmune disease in which beta-cells are destroyed due to an aberrant immune response, resulting in the loss of the pancreas’ ability to produce insulin, the hormone that controls blood-sugar levels. While T1D is a lifelong disease that impacts people of all ages, the onset of T1D most often occurs in children and adolescents. Imcyse is advancing its lead development candidate, IMCY-0098, in a Phase 2 clinical trial for the treatment of T1D. IMCY-0098 is a novel, insulin-based modified synthetic peptide – also known as an Imotope™ – that intervenes early in the autoimmune response to stop the destruction of beta-cells and maintains the ability of the pancreas to produce insulin.
In the EXALT study, a double-blind, placebo-controlled, dose-escalation Phase 1b clinical trial, 41 adults were enrolled from seven European countries measuring clinical and immunological read-outs. The study met its primary endpoint and results were presented at the 55th annual meeting of the European Association for the Study of Diabetes (EASD) in September 2019. IMCY-0098 was found to be safe and well tolerated with early signs of activity detected as well as an immunological response in line with the expected mechanism of action.
IMCY-0098 is now being studied in the IMPACT (IMCY-0098 Proof of ACtion in Type 1 Diabetes) trial, a multicenter, randomized, double-blind, placebo-controlled study in patients with early T1D in which treated the first patient in January 2021. This Phase 2 clinical trial is evaluating the clinical proof of concept of the treatment with IMCY-0098 in adults. The data collected will also allow an extensive characterization of the immune signature of IMCY-0098 following treatment including evaluation of its potential effect to preserve the body’s ability to produce insulin. Leading T1D KOL Prof. Dr. Chantal Mathieu serves as Chief Investigator, and the program is conducted in partnership with INNODIA, a European consortium of 40 members including academic institutions, industrial partners and patient organizations bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". This project runs under the framework of the Innovative Medicines Initiative – Joint Undertaking (IMI-JU). In January 2022, the U.S. FDA accepted Imcyse’s IND application for the IMPACT trial.
The Company has also reported positive immune responses from an interim analysis of 17 patients enrolled in the Phase 2 IMPACT T1D study. Data from Imotope™ treated groups point to a number of findings supportive of the mechanism of action of Imotopes.
Imcyse’s Multiple Sclerosis (MS) development candidate, IMCY-0141, is currently studying patients in an adaptive phase 1 / 2 study. In cases of MS, the body’s own immune system attacks the central nervous system and causes damage, which slows or stops nerve transmission. Imcyse has developed an Imotope™ based on Myelin Oligodendrocyte Glycoprotein (MOG) to stop immune attacks to the central nervous system and thereby enable uninterrupted nerve transmission. The efficacy of IMCY-0141 has been demonstrated in several EAE pre-clinical models.
The adaptive Phase 1 /2 clinical trial will evaluate the safety profile and recommended Phase 2 dose, as well as preliminary efficacy results, of IMCY-0141.
Looking beyond T1D and MS, Imcyse has also initiated a pre-clinical studies in neuromyelitis optica spectrum disorder (NMOSD) and Celiac Disease.
In the field of rheumatoid arthritis (RA), we have entered into a research collaboration and license agreement with Pfizer.
Other early stage, preclinical programs include proof-of-concept studies in allergy, graft vs. host rejection, myasthenia gravis as well as in the prevention of immunogenicity in gene therapy using AAV-Vectors.