Eledon Pharmaceuticals (ELDN) Leerink’s Global Healthcare Conference 2025 summary

Key clinical program updates

• Anticipates major data readouts in 2024, including Phase 1b renal transplant data in August and top-line Phase 2 BESTOW results in Q4.

• Phase 1b study shows mean eGFR in high 60s, outperforming standard tacrolimus regimens.

• BESTOW Phase 2 is a global, superiority-designed trial with 120 subjects, powered to detect a nine-point eGFR difference.

• Islet cell transplant study at University of Chicago shows two of three patients off exogenous insulin post-transplant.

• Xenotransplant collaborations with eGenesis and United Therapeutics are advancing, with ongoing clinical studies.

Mechanistic and safety insights

• Tegoprubart targets CD40 ligand, offering a differentiated approach from CD40 receptor-targeted therapies.

• Blocking CD40 ligand has shown robust efficacy in preventing transplant rejection across species.

• Safety profile across studies and the drug class remains favorable, with no increase in opportunistic infections or malignancy.

• Phase 1b safety events included alopecia, bacteremia, and one T cell-mediated rejection, with most patients continuing in extension studies.

Regulatory and future development plans

• Phase 3 study will be designed post-BESTOW readout, likely expanding global footprint and patient numbers.

• iBox as a potential endpoint is under regulatory review, with clarity expected in Q1 next year.

• iBox could enable superiority designs in future trials, but requires comprehensive data collection.