공시 • Jun 22
Eledon Pharmaceuticals Announces Long-Term Extension Phase 2 BESTOW Results for Tegoprubart in Kidney Transplantation
Eledon Pharmaceuticals, Inc. announced new long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented in oral and poster presentations at the American Transplant Congress (ATC) taking place June 20-24, 2026, in Boston, Massachusetts. The presentations highlight updated results from the Phase 2 BESTOW trial and new long-term follow-up data from the Phase 2 BESTOW extension study. Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p. No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm. Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden. Among patients who completed 12 months of treatment in the BESTOW study, 96% (49/51) of tegoprubart-treated patients and 86% (48/56) of tacrolimus-treated patients entered the BESTOW long-term extension study. As of the data cutoff, mean follow-up was 21 months, with: 89 patients followed through 18 months, 20 patients followed through 24 months, and the longest-followed ongoing patient followed for approximately 33 months. Kidney graft function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month of treatment and remained higher in tegoprubart-treated patients than in tacrolimus-treated patients at each reported time point. At month 18, tegoprubart-treated patients demonstrated a statistically significant approximately 12 mL/min/1.73 m² higher mean eGFR compared with tacrolimus-treated patients (74 vs. 61 mL/min/1.73 m²; p. In the BESTOW long-term extension study, key central nervous system and kidney-related adverse events were observed more frequently in the tacrolimus arm than in the tegoprubart arm, including headache (12% vs. 2%), extremity pain (10% vs. 0%), fall or loss of balance (6% vs. 0%), and acute kidney injury (6% vs. 2%), respectively. Diarrhea was observed more frequently in the tacrolimus arm than in the tegoprubart arm during long-term follow-up (21% vs. 10%, respectively). This pattern was consistent with the first-year BESTOW results, in which diarrhea was reported in 34% of tacrolimus-treated patients vs. in 22% of tegoprubart-treated patients. No graft loss, no progressive multifocal leukoencephalopathy (PML), no post-transplant lymphoproliferative disorder (PTLD), no BK or CMV nephropathy/disease, and no new malignancies were reported in the BESTOW long-term extension study. No new proteinuria was reported on the tegoprubart arm. One death occurred in the tegoprubart arm and was not attributed to study drug. Following a successful FDA End-of-Phase 2 meeting, Eledon has established the regulatory framework for its Phase 3 kidney transplantation program and plans to initiate Phase 3 clinical development of tegoprubart in late 2026. The Phase 3 primary endpoint is expected to be non-inferiority versus tacrolimus at 52 weeks on a composite of BPAR, graft loss and death. The Phase 3 study will also incorporate key learnings from the Phase 2 BESTOW trial and ongoing long-term extension study, including evidence of sustained kidney function benefit, favorable rejection outcomes, and improved patient-reported outcomes. Full details of the ATC oral presentation are below: Title: Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy in Preventing Kidney Transplant Rejection. Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview. Abstract Publication Number: 585. Session Title: Emerging Discoveries Oral Abstract Session - Kidney: Biomarkers -3. Session Date and Time: Monday, June 22, 2026, from 11:15 a.m. - 12:15 p.m. ET. Session Room: 253BC (Level 2). Presentation Time:12:03 p.m. - 12:15 p.m. ET.