Eledon Pharmaceuticals (ELDN) investor relations material

Study background, design, and patient population

• Phase II BESTOW was a prospective, multicenter, randomized, open-label trial comparing tegoprubart to tacrolimus in de novo kidney transplant recipients, enrolling 127 patients across 44 global sites.

• Participants were randomized 1:1 to receive either tegoprubart or tacrolimus, with both arms receiving standard induction and maintenance immunosuppression.

• The primary endpoint was change in eGFR at 12 months, with secondary endpoints including a composite of biopsy-proven acute rejection, graft loss, death, iBox score, DSAs, delayed graft function, and new-onset diabetes.

• Subgroup analyses included living vs. deceased donors and kidney quality (KDPI scores).

• Patients could continue in a long-term extension study for further follow-up.

Efficacy results

• Tegoprubart demonstrated non-inferiority to tacrolimus for the composite endpoint, with failure rates within the 20% non-inferiority margin and meeting the FDA approvable standard.

• Mean eGFR at 12 months was 69 mL/min/1.73m² for tegoprubart and 66 mL/min/1.73m² for tacrolimus, with tegoprubart numerically superior at all time points but not statistically significant overall.

• Subgroup analyses showed tegoprubart had particular benefit in living donor and high KDPI deceased donor subgroups.

• Acute rejection rates were higher with tegoprubart (20.6%) vs. tacrolimus (14.1%), but rejections on tegoprubart occurred early and were manageable; patients remaining on tegoprubart after rejection maintained better kidney function.

• DSA cases were low in both arms (1 for tegoprubart, 2 for tacrolimus), and the abbreviated iBox score at 12 months for tegoprubart was comparable to or better than historical controls.

Safety and adverse events

• Tegoprubart had a favorable safety profile, with significant reductions in new-onset diabetes, tremors, hypertension, delayed graft function, and cardiovascular events compared to tacrolimus.

• Tacrolimus was associated with more cases of diabetes (7x higher), hyperkalemia, tremors, muscle spasms, and hypertensive crises.

• Tegoprubart had more cases of proteinuria and hypophosphatemia, mostly transient and low-grade, except in patients with recurrent underlying disease.

• Delayed graft function and dialysis duration were reduced with tegoprubart, while sepsis/bacteremia was less frequent; opportunistic infection rates were similar between groups.

• Both arms had similar rates of serious adverse events, including death and graft loss.