Eledon Pharmaceuticals Inc (ELDN) News & EventsELDNEledon Pharmaceuticals Inc

Eledon Pharmaceuticals Reports Positive Data from Tegoprubart Clinical Trial

Eledon Pharmaceuticals announced new patient-reported outcomes data from the Phase 2 BESTOW clinical trial of tegoprubart, its novel investigational immunosuppression therapy. The data showed significant, sustained improvements in health-related quality of life and symptom burden through 12 months compared with standard of care tacrolimus following kidney transplantation. The results were featured in an oral presentation at the American Society of Nephrology, or ASN, Kidney Week 2026 Annual Meeting held October 21-25 in Denver, Colorado. Patient-reported outcomes were assessed using the Modified Transplant Symptom Occurrence and Symptom Distress Scale and the Kidney Disease Quality of Life Short Form Symptoms and Problems Scale, both validated measures of symptom burden. Baseline scores were similar between treatment groups. Collectively, the consistency of findings across both the KDQOL-SF and MTSOSD-59R assessments suggests that reductions in transplant-related symptom burden with tegoprubart may contribute to the improvements observed in patient-reported quality of life and further supports the differentiated clinical profile of tegoprubart compared to tacrolimus observed in the Phase 2 BESTOW clinical trial. On the MTSOSD-59R assessment, tegoprubart-treated patients reported continued reductions in symptom occurrence from baseline at Months 6 and 12, whereas symptom occurrence in the tacrolimus arm initially declined through Month 6 before returning to slightly above baseline levels at Month 12. Tegoprubart demonstrated greater symptom improvement than tacrolimus in 22 of 23 domains where differential improvement was observed, including neurological, gastrointestinal, metabolic, and physical symptom categories. In addition, tacrolimus demonstrated greater symptom worsening in 22 of 22 domains where differential symptom worsening was observed. On the KDQOL-SF assessment, kidney transplant patients treated with tegoprubart demonstrated improvements from baseline across all five subscales through Month 12. In the KDQOL-SF scale, a change of 3-5 points can be considered clinically significant, and tegoprubart was thus associated with a clinically and statistically significant improvement in the symptoms and problems subscale compared with tacrolimus at Month 12, with mean changes from baseline of 9.0 and 3.3 points, respectively. Consistent with these findings, the SF-12 mental component summary score increased by 1.5 points in the tegoprubart arm compared to a decline of 1.6 points in the tacrolimus arm, representing a 3.1-point between-group difference.

Eledon Pharmaceuticals Updates Kidney Transplant Data, FDA Grants Fast Track

Eledon Pharmaceuticals announced updated long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented at the International Congress of The Transplantation Society, taking place September 20-23, 2026, in Sydney, Australia. The Company also announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to tegoprubart for the prevention of rejection in kidney transplantation. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation, LEGACY, in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority of tegoprubart versus tacrolimus on a composite efficacy failure endpoint at 12 months, defined as a combination of biopsy-proven acute rejection, graft loss, and death.

Eledon Pharmaceuticals Achieves Significant Progress in Kidney Transplant Development

Eledon Pharmaceuticals announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. Eledon has submitted an Investigational New Drug application to the FDA for a planned company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon's first company-sponsored clinical trial in islet cell transplantation and represents an important step in the company's registrational pathway for tegoprubart in this patient population. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor-free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor-related renal dysfunction. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation, LEGACY, in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection, graft loss, and death. The first highly sensitized kidney transplant patient has been dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital.