Eledon Pharmaceuticals (ELDN) Study result summary

Program and Study Updates

• Tegoprubart is being evaluated in five transplant programs, including kidney and islet cell transplantation, with ongoing Phase 1b, Phase 2, and long-term extension studies.

• Subcutaneous formulation of tegoprubart completed healthy volunteer study; transplant patient testing expected early next year.

• New clinical trial initiated for kidney transplant tolerance induction at Massachusetts General Hospital, with two patients transplanted.

• 96% of phase II BESTOW study patients chose to remain on tegoprubart after 52 weeks, indicating high satisfaction.

• Phase III kidney transplant study to launch by year-end, enrolling ~600 patients globally, with FDA clearance received.

Study Design and Pipeline Overview

• The Phase 2 BESTOW trial is a head-to-head, superiority study comparing tegoprubart to tacrolimus in kidney transplant recipients, with long-term extension data available.

• Phase III trial is planned to assess tegoprubart in a CNI-free regimen for kidney transplant rejection prevention, targeting non-inferiority on a composite efficacy endpoint.

• The Phase 2 BESTOW study included a long-term extension, with most patients continuing into the extension and follow-up up to 33 months.

Efficacy Results in Kidney Transplantation

• Tegoprubart-treated patients maintained a statistically significant higher mean eGFR at 18 months post-transplant, with a 12 mL/min/1.73 m² advantage over tacrolimus (74 vs. 61; p<0.05).

• No biopsy-proven acute rejection (BPAR) in the tegoprubart arm after six months, while the tacrolimus arm had ongoing rejections, including late antibody-mediated cases.

• Patients remaining on tegoprubart after rejection had better kidney function than those switched to tacrolimus.

• Long-term data from phase I-b mirrored phase II, with no BPAR after six months and higher eGFR for those staying on tegoprubart, with some patients followed for up to 3.5 years.

• Rates of BPAR were similar between arms, but tegoprubart patients who experienced rejection maintained higher kidney function.