Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) reported that all 12 patients in an investigator-initiated trial achieved insulin independence following islet transplantation using its experimental drug tegoprubart.

The study, conducted at University of Chicago Medicine, showed patients no longer required external insulin therapy to manage their type 1 diabetes after receiving the treatment. All participants also achieved hemoglobin A1C levels below 6.5%, with an average of approximately 5.4%, representing an improvement of about 2.6% from baseline levels.

No severe hypoglycemic episodes occurred post-transplant, compared to all patients experiencing recurrent severe episodes before treatment. The study followed patients for a median of 8 months and maximum of 22 months after transplantation.

The trial used tegoprubart as part of a calcineurin inhibitor-free immunosuppression regimen. Traditional immunosuppression drugs like tacrolimus can cause kidney toxicity, hypertension and neurological side effects. No rejection episodes occurred, and no patients developed donor-specific antibodies against the transplanted islets.

The 12 adult participants had type 1 diabetes for a median duration of approximately 33 years with mean baseline hemoglobin A1C levels of about 8.0%. Results were presented at the American Diabetes Association's 86th Scientific Sessions in New Orleans.

Breakthrough T1D funded the study, with initial support from The Cure Alliance. The organization has committed to fund a second study evaluating the drug in type 1 diabetes patients with chronic kidney disease.

Eledon plans to work with the FDA toward receiving regulatory guidance for tegoprubart in islet cell transplantation later this year, according to information based on the company's press release.