Eledon Pharmaceuticals reported that the first six patients enrolled in its investigator‑initiated islet‑cell transplant trial at the University of Chicago Medicine achieved insulin independence while receiving tegoprubart as the core immunosuppressant. The patients, all with type‑1 diabetes, maintained hemoglobin A1c levels below 6% for up to 15 months and experienced no severe hypoglycemic episodes.
The safety profile of tegoprubart was also encouraging. None of the six subjects developed serious infections, thromboembolic events, or the kidney or neurological toxicity that is commonly associated with calcineurin‑based regimens such as tacrolimus. The data support the hypothesis that tegoprubart can replace tacrolimus in islet transplantation.
Eledon’s lead antibody is an engineered anti‑CD40 ligand designed to avoid platelet activation while preserving potent immunomodulation. CEO David‑Alexandre C. Gros emphasized that the absence of calcineurin‑related toxicities “underscores the potential of tegoprubart to provide a safer alternative for transplant patients.” The results may accelerate the company’s broader strategy to position tegoprubart as a safer immunosuppressant for both islet and solid‑organ transplantation, potentially expanding its market beyond kidney transplantation.
The trial was presented at the Rachmiel Levine‑Arthur Riggs Diabetes Research Symposium, held November 14‑17, 2025, and the announcement was made on November 18, 2025. The investigator‑initiated study has been extended to 12 subjects, and funding from Breakthrough T1D supports continued enrollment and data collection.
While the findings are promising, the sample size is small and follow‑up is limited. Larger, longer‑term studies are required to confirm durability and generalizability of the safety and efficacy signals.
Investors responded positively to the announcement, noting the significance of the data for Eledon’s pipeline and the broader transplant market.
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