Eledon Pharma Reports Positive Early Results from Type 1 Diabetes Tegoprubart Trial at UChicago Medicine

Eledon Pharmaceuticals, Inc. has reported promising outcomes for three patients who received islet transplants as part of an experimental immunosuppression regimen that includes tegoprubart, their investigational anti-CD40L antibody. This regimen aims to prevent islet transplant rejection in individuals with type 1 diabetes (T1D). The trial, initiated by researchers at the University of Chicago Medicine's Transplantation Institute, marks an innovative approach by demonstrating potential insulin independence in humans using an anti-CD40L monoclonal antibody therapy without tacrolimus, the standard care drug for transplant rejection prevention.

The first two subjects in the study attained insulin independence and exhibited normal hemoglobin A1C (HbA1c) levels, which is an indicator of average blood sugar, post-transplant. The third subject, who recently received an islet transplant, reduced insulin usage by over 60% within three days of the procedure and is progressing toward insulin independence. These subjects received islet transplants with induction therapy, mycophenolate mofetil (MMF), and tegoprubart administered every third week intravenously.

The initial two subjects showed stable islet graft function at approximately three and six months post-transplant, respectively. Notably, islet engraftment in these subjects was estimated to be three to five times higher than that of three comparable subjects who received tacrolimus-based immunosuppression, indicating that tegoprubart might be less harmful to transplanted islets, thus enhancing graft survival and functionality. The treatment was generally well tolerated, with no unexpected side effects or hypoglycemic incidents reported.

Following the initial islet transplant, the first participant reduced insulin needs by more than 60% and maintained normal blood glucose control. After a second islet transplant, this participant achieved insulin independence about two weeks later. The second participant, a 30-year-old female, stopped requiring insulin support four weeks after the islet transplant, with her HbA1c levels improving significantly. The third participant, a 37-year-old male, saw a substantial reduction in insulin requirements shortly after the transplant.

The study data were presented at the 5th IPITA/HSCI/Breakthrough T1D Stem Cells Summit. According to Piotr Witkowski, M.D., Ph.D., from the University of Chicago Medicine, this research represents a significant advancement in finding immunosuppression options that do not have the severe side effects associated with standard care, such as toxicity to the kidneys and central nervous system, and increased risks of diabetes and hypertension.

The success of this study highlights tegoprubart as a potentially transformative immunosuppression option for islet transplantation, offering a new avenue for those with type 1 diabetes. Sanjoy Dutta, Ph.D., Chief Scientific Officer of Breakthrough T1D, expressed optimism about the potential of islet replacement therapies and the promising results of the tegoprubart study.

Eledon Pharmaceuticals is dedicated to developing immune-modulating therapies for critical conditions, with tegoprubart being their lead investigational product. This anti-CD40L antibody aims to offer a non-lymphocyte depleting, immunomodulatory therapeutic approach, validating its broad therapeutic potential. The company's ongoing commitment to advancing this therapy through clinical trials seeks to provide effective solutions for transplant rejection prevention in various medical contexts.