Eledon to prioritize resources on tegoprubart in kidney transplantation

Eledon Pharmaceuticals announced a business update aimed at maximizing shareholder value by prioritizing resources on its ongoing clinical development efforts in kidney transplantation. Every year more than 24,000 people undergo a kidney transplant in the United States, and over 240,000 Americans are living with a functioning transplanted kidney. Eledon’s investigational drug candidate, tegoprubart, seeks to address the challenges associated with current immunosuppressive transplantation regimens, such as those that administer calcineurin inhibitors. The ability to prevent acute and chronic transplant rejection without the need for CNIs has the potential to transform the clinical management of transplantation by mitigating the nephrotoxicity and other side effects associated with CNIs, and potentially increasing the functional life of transplanted organs. Kidney Transplantation: The Company received regulatory clearance to initiate a Phase 1b open-label trial in Canada, the United Kingdom and Australia, for up to twelve patients, evaluating tegoprubart as a replacement for tacrolimus as a component of an immunosuppressive regimen in patients undergoing kidney transplantation. Enrollment is currently ongoing, with three patients dosed in the second half of 2022. The Company received Investigational New Drug application clearance from the U.S. Food and Drug Administration for BESTOW, a Phase 2 trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney allograft. BESTOW will be a multicenter, open-label, active control, trial to assess the safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. The trial’s primary endpoint is mean eGFR at one year post-transplantation. Secondary objectives include safety, incidence of new onset diabetes, biopsy-proven rejection, and graft survival. The trial will enroll approximately 120 participants undergoing kidney transplant and will run in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation. BESTOW includes an open-label extension trial allowing for the collection of long-term efficacy and safety from both this Phase 2 as well as the ongoing Phase 1b trial. The Company announced a collaboration agreement with eGenesis for the use of tegoprubart in preclinical xenotransplantation studies. Anti-CD40L costimulatory blockade has been demonstrated as a key component of effective immunosuppressive regimens to suppress xenograft rejection in non-human primate models of organ transplantation. IgAN: The Company received IND application clearance from the FDA to evaluate tegoprubart for the treatment of IgAN. This global clinical trial is a 96-week open-label clinical trial that may include up to 42 total participants, equally split between an initial high dose and a potential subsequent low dose cohort. Ten patients have been dosed to date in the high dose cohort. Amyotrophic Lateral Sclerosis: In mid-2022, the Company announced positive topline results from a Phase 2a trial of tegoprubart in patients with ALS. Tegoprubart successfully met the primary endpoints of safety and tolerability, with no drug-related serious adverse events. Tegoprubart treatment was associated with dose dependent target engagement and a reduction in pro-inflammatory biomarkers in circulation. The Company continues to work closely with key stakeholders on potential next steps, as well as evaluating a range of approaches to fund a potential future trial. Anticipated 2023 Milestones: 1Q 2023: initial three and six-month open-label data from the Phase 1b trial of tegoprubart in kidney transplantation. 1Q 2023: initial open-label safety data from the Phase 2a trial of tegoprubart in IgAN. Mid-2023: initiate Phase 2 BESTOW trial of tegoprubart in kidney transplantation. 2H 2023: complete enrollment in Phase 1b trial of tegoprubart in kidney transplantation.