COUR Pharma Doses First Patient in Clinical Trial Evaluating CNP-103 in People Recently Diagnosed with Type 1 Diabetes
CHICAGO, Aug. 19, 2025 (GLOBE NEWSWIRE) -- COUR Pharma, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies to treat autoimmune diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial for CNP-103, a tolerogenic nanoparticle therapy in development to address the underlying autoimmunity associated with type 1 diabetes (T1D).
“The initiation of this trial is important for patients, as we believe our approach to antigen-specific immune tolerance offers the potential to surpass symptom management and instead directly address the underlying autoimmunity present in people with T1D,” said Dannielle Appelhans, President and Chief Executive Officer of COUR. “While CNP-103 has potential across stages 1 through 3 in T1D and potentially in later-stage patients in combination with islet cell transplants, our initial focus is on stage 3, for which there are no FDA-approved disease-modifying therapies to combat autoimmune β-cell destruction. In addition to safety, the trial for CNP-103 will evaluate the ability of CNP-103 to preserve islet cell function through the maintenance of C-peptide levels.”
The Phase 1b/2a study (NCT06783309) will assess the safety of CNP-103 in adults, aged 18-35, and pediatrics, aged 12-17, who have stage 3 newly diagnosed (within the last six months) T1D as well as C-peptide >0.2 nmol/L.
About CNP-103:
CNP-103 is a biodegradable nanoparticle encapsulating four recombinant proteins which can reprogram the inflammatory autoimmune response directed toward islet cell destruction: preproinsulin, GAD65, IGRP, ZnT8. Notably, these proteins cover >95% of known antigens driving type 1 diabetes. By inducing tolerance to these proteins, COUR aims to prevent further islet cell destruction by pathogenic CD4+ and CD8+ T cells, and maintain insulin production at a clinically important level and potentially reverse dysglycemia.
About Type 1 Diabetes (T1D):
T1D is a progressive disorder impacting >1.5 million individuals in the U.S. and is caused by autoreactive pathogenic CD4+ and CD8+ T cells targeting insulin-producing β-cells in the islets of Langerhans, causing destruction. Progressive β-cell loss results in insulin deficiency and inability to regulate glucose. People who live with T1D experience symptoms that include acutely frequent urination, excessive thirst, weight loss, fatigue, and potentially life-threatening diabetic ketoacidosis. Broader health impacts of T1D include heart disease, kidney failure, stroke, and vision loss.
About COUR Pharma:
COUR Pharma is a clinical-stage biotechnology company developing therapies to treat patients with autoimmune diseases. COUR’s first-in-class therapies are based on our proprietary antigen-specific immune tolerance platform and are designed to reprogram the immune system to address the underlying root cause of immune-mediated diseases. Data from multiple clinical and preclinical programs have demonstrated the ability of COUR’s product candidates to induce antigen-specific immune tolerance and have the potential to treat a wide range of autoimmune diseases.
COUR is enrolling patients in two Phase 1b/2a clinical studies: one in myasthenia gravis (MG) and the other in type 1 diabetes. COUR also expects to initiate a Phase 2b in primary biliary cholangitis (PBC), a disease in which COUR has already shown positive results in a Phase 1b/2a study, in 2025. Additionally, COUR has partnered with Takeda Pharmaceuticals for its program in celiac disease, which is currently enrolling in a Phase 2b trial, and is developing an undisclosed preclinical stage program in collaboration with Genentech.
For more information, please visit www.courpharma.com.
Contacts
For Investor Relations
Brian Bock, Chief Financial Officer
bbock@courpharma.com
For Media
Jason Braco
jbraco@lifescicomms.com
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