Eledon Establishes Framework for Pivotal Kidney Transplant Trial
Eledon plans to enroll about 600 patients in a global tegoprubart trial starting in late 2026 after completing a meeting with U.S. regulators.
Eledon Pharmaceuticals, Inc. (ELDN), a clinical-stage biotechnology company, moved its kidney-transplant program from awaiting regulatory alignment to an established framework for a pivotal trial. The company completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration during the second quarter. Its March and May updates had listed regulatory guidance as an outstanding milestone; Eledon now expects to begin its Phase 3 tegoprubart study later this year.
The planned trial gives the kidney program a defined next step following those earlier updates. Eledon said the primary endpoint will test non-inferiority against tacrolimus at 52 weeks, using a composite of biopsy-proven acute rejection, graft loss and death. Tacrolimus was the standard-of-care immunosuppression treatment against which the company also presented its latest kidney-function results.
At 18 months in the Phase 2 BESTOW program, mean estimated glomerular filtration rate, a measure of kidney function, was approximately 74 mL/min/1.73 m² with tegoprubart versus approximately 61 mL/min/1.73 m² with tacrolimus. The difference was statistically significant.
No biopsy-proven acute rejection events occurred in tegoprubart-treated patients after the first six months following transplantation. The tacrolimus arm recorded seven such events. Patient-reported outcomes at 52 weeks favored tegoprubart on two validated measures of symptom burden, while long-term safety and tolerability findings from the BESTOW extension were favorable.
Eledon added a monitoring partner for the pivotal study, entering an agreement with Natera to use its Prospera kidney transplant assessment test as the exclusive donor-derived cell-free DNA assay. Separately, the first two patients received treatment in an investigator-initiated kidney-transplant tolerance-induction study at Massachusetts General Hospital. Starting that study had remained on the company's milestone list in the preceding quarter.
The islet-cell program also moved beyond the results repeated in the two earlier updates. All 12 patients with type 1 diabetes in the University of Chicago Medicine investigator-initiated study achieved insulin independence. The preceding reports had established that outcome for the 10 patients who were more than four weeks past transplantation, rather than for the entire treated group.
Mean most recent HbA1c was approximately 5.4%, and no severe hypoglycemic episodes were reported after transplantation. Islet graft function remained stable through a maximum follow-up of 22 months, and tegoprubart was generally well tolerated. The company plans a sponsored registration-path study in islet-cell transplantation, alongside investigator-led studies involving islet recipients with renal dysfunction and patients receiving a new liver transplant.
The financial results presented a different trajectory from the clinical milestones. Eledon's second-quarter net loss widened to $31.6 million, or $0.27 a share, from $11.2 million a year earlier. The reported loss therefore grew during a quarter in which research and development expenses were lower than in the corresponding period.
Warrant accounting explained the divergence. The quarter included a $9.6 million non-cash loss from changes in warrant-liability fair value, whereas the comparable period contained a $12.3 million gain. Excluding those changes, the company's quarterly net loss would have been $22.0 million against $23.5 million a year earlier.
Research and development expenses were $18.2 million for the quarter, including $2.1 million in non-cash stock compensation. General and administrative expenses totaled $4.6 million. Those were the operating expense categories as the company continued developing its lead investigational antibody across transplantation settings.
Cash, cash equivalents and short-term investments declined for a second consecutive quarter, reaching $88.8 million at June's end after $111.1 million in March and $133.3 million at year-end. Eledon expects those resources to fund operations into the second quarter of 2027, leaving its stated funding horizon extending beyond the planned late-2026 launch of the pivotal kidney trial.
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