Eledon Shares New Data from Phase 1b Trial on Tegoprubart for Kidney Transplant Rejection Prevention

IRVINE, Calif., June 03, 2024 – Eledon Pharmaceuticals, Inc. has revealed new data from its ongoing Phase 1b clinical trial and open-label extension study on tegoprubart, a potential new agent for preventing organ rejection in kidney transplant patients. The findings were shared at the American Transplant Congress (ATC) in Philadelphia, PA, held from June 1-5, 2024.

The poster presentation, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” highlighted encouraging safety and efficacy data for tegoprubart. According to Dr. David-Alexandre C. Gros, Chief Executive Officer of Eledon, these results reinforce the potential of tegoprubart to become a next-generation immunosuppressive agent, offering an alternative to current calcineurin inhibitors which often present challenging side effects.

As of the April 2024 cutoff date, data from 13 participants in the Phase 1b trial indicate that tegoprubart may effectively protect kidney function post-transplantation. Historically, patients treated with calcineurin inhibitor-based therapy experience mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m² within the first year after a kidney transplant. In contrast, the ongoing Phase 1b trial reported mean eGFR values above 60 mL/min/1.73m² at all time points post day 30, with an overall mean eGFR of 70.5 mL/min/1.73m². Notably, two participants who completed 12 months of therapy exhibited mean eGFRs above 90 mL/min/1.73m².

Safety data revealed that tegoprubart is generally well-tolerated by participants. Three subjects discontinued the study due to issues such as hair loss and fatigue, viral infection, and rejection. Importantly, no incidents of hyperglycemia, new onset diabetes, or tremor were noted—side effects commonly associated with standard immunosuppression therapy. Additionally, no cases of graft loss or death were reported.

Eledon is actively conducting a Phase 1b trial (NCT05027906), a Phase 2 BESTOW trial (NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to further explore the effectiveness of tegoprubart in preventing organ rejection in kidney transplant recipients. The company aims to complete enrollment for the Phase 2 trial by the end of the year.

About Eledon Pharmaceuticals and Tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical-stage biotech company focused on developing therapies that modulate the immune system to treat life-threatening conditions. The company’s lead investigational drug, tegoprubart, is an anti-CD40L antibody with a strong affinity for the CD40 Ligand. This target plays a critical role in immune cell activation and function, making it a promising candidate for non-lymphocyte depleting immunomodulatory treatment. Eledon is leveraging its deep understanding of anti-CD40 Ligand biology to conduct preclinical and clinical trials in areas such as kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). The company is headquartered in Irvine, California.

The promising results and ongoing studies underscore Eledon Pharmaceuticals’ commitment to advancing tegoprubart as a safer and more effective immunosuppressive therapy for kidney transplant patients. As data accrues, the company remains optimistic about the potential of tegoprubart to improve outcomes for transplant recipients.

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