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Eledon Pharmaceuticals (ELDN) Update / Briefing Transcript
2025-08-06 21:30
Summary of Eledon Pharmaceuticals (ELDN) Update / Briefing August 06, 2025 Company Overview - **Company**: Eledon Pharmaceuticals (ELDN) - **Focus**: Development of tegoprovart for kidney transplantation Key Industry Insights - **Industry**: Kidney transplantation and immunosuppression therapies - **Event**: Presentation of updated Phase 1b trial results at the World Transplant Congress Core Points and Arguments 1. **Phase 1b Trial Results**: Eledon presented updated results from the Phase 1b trial of tegoprovart, which is being evaluated as a cornerstone immunosuppression therapy in de novo kidney transplantation [3][6][8] 2. **Safety and Efficacy**: The trial demonstrated good safety and tolerability for tegoprovart, with twelve-month eGFR (estimated Glomerular Filtration Rate) results indicating good kidney function [8][26] 3. **Rejection Episodes**: A total of six rejection episodes were reported, with a 19% incidence rate. Most rejections occurred in patients receiving lower doses of ATG (antithymocyte globulin) induction therapy [21][24] 4. **Long-term Predictive Endpoints**: The trial included the abbreviated IBOX score, which is being developed as a surrogate endpoint to predict five-year graft survival. The IBOX score showed strong predictive capabilities [31][35] 5. **Regulatory Considerations**: Eledon is in discussions with regulatory bodies regarding the use of IBOX as a potential endpoint for future clinical trials, with expectations for feedback in the second half of the following year [31][59] Additional Important Content 1. **Patient Demographics**: The study included 32 patients with a mean age of 52.9 years, with 75% being living donors. Notably, 56% of patients had an HLA mismatch of more than five, indicating a higher immunological risk [15][16][94] 2. **Infection Rates**: The trial reported manageable infection rates, with no cases of graft loss. The infections were controllable, and the study aims to explore lower dosing to potentially improve safety outcomes [90][91] 3. **Impact of Improved Graft Survival**: A hypothetical 5% improvement in five-year graft survival could significantly reduce the number of patients dying while waiting for a kidney transplant, potentially allowing for 1,500 additional kidneys to be available each year [41][43] 4. **Future Studies**: Eledon is preparing for the Phase II BISTOLE study, with results expected to be presented in the fourth quarter of the year [44] Conclusion Eledon Pharmaceuticals is making significant strides in the development of tegoprovart for kidney transplantation, with promising Phase 1b trial results indicating good safety and efficacy. The company is focused on regulatory discussions regarding the IBOX score as a predictive endpoint for long-term graft survival, which could have a substantial impact on patient outcomes in the field of kidney transplantation.