COUR Pharmaceuticals receives FDA approval for IND application of CNP-103 for Type 1 diabetes.
Wednesday, February 05, 2025
COUR Pharmaceuticals, a biotechnology company focused on developing treatments for immune-related diseases, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for CNP-103. This nanoparticle therapy aims to address the underlying autoimmunity in Type 1 diabetes (T1D).
CNP-103 is the third autoimmune disease programme from COUR to enter clinical trials using its nanoparticle platform designed to promote immune tolerance. In preclinical studies, the therapy has shown potential to slow disease progression, reduce inflammation, and create a more balanced immune response. It is expected that CNP-103 could help maintain β-cell function and improve glucose regulation. A Phase 1b/2a clinical trial is planned to begin later this year.
The upcoming study will evaluate the safety of CNP-103 in adults aged 18-35 and children aged 12-17 who have Stage III or recently diagnosed (within six months) T1D and a C-peptide level above 0.2 ng/mL.
CNP-103 is a biodegradable nanoparticle containing four recombinant proteins linked to islet cell destruction: preproinsulin, GAD65, IGRP, and ZnT8. These proteins account for over 95% of known antigens responsible for T1D. By promoting immune tolerance to these proteins, COUR aims to prevent islet cell damage, preserve insulin production, and potentially reverse glucose imbalances.
T1D is a progressive condition affecting more than 1.5 million people in the U.S. It is caused by an immune response where CD4+ and CD8+ T cells attack insulin-producing β-cells in the pancreas, leading to insulin deficiency and difficulty in regulating blood sugar levels. Symptoms include frequent urination, excessive thirst, weight loss, fatigue, and, in severe cases, diabetic ketoacidosis. The condition also increases the risk of complications such as heart disease, kidney failure, stroke, and vision loss.
Source: globenewswire.com
