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Eledon Pharmaceuticals (ELDN) investor relations material
Eledon Pharmaceuticals Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key clinical results and safety profile
Phase 2 BESTOW trial showed tegoprubart was not inferior to tacrolimus in efficacy for kidney transplant patients, with a strong safety profile.
Over 150 patients have used tegoprubart, building a robust efficacy and safety database.
Tegoprubart demonstrated some of the highest graft function seen in clinical trials, with mean eGFR of 69 vs. 66 for tacrolimus over 52 weeks.
Adverse events were similar in number and severity, but tegoprubart had fewer serious side effects such as bacteremia, hyperglycemia, new-onset diabetes, hyperkalemia, tremors, and delayed graft function.
Patients on tacrolimus experienced more post-transplant dialysis days, higher rates of hypertension, heart failure, and other complications.
Strategic development and market focus
Sufficient funding secured to operate through Q2 2027, following a recent $57.5 million financing.
Plans to approach the FDA in the first half of next year to discuss phase 3 approval pathway for kidney transplantation.
Phase 3 trial expected to launch in the second half of the year, with 200-300 patients per arm, focusing on triple endpoints for non-inferiority.
Tegoprubart development is focused on transplantation, including kidney, islet cell, xenotransplantation, and liver programs.
Collaborations ongoing in xenotransplantation with United Therapeutics and eGenesis, with upcoming studies in cardiac and kidney xeno.
Market landscape and unmet needs
Kidney transplantation is the largest segment, with about 27,000 procedures annually in the U.S. and 100,000 patients on the waitlist.
Current standard of care, tacrolimus, is a $1.5 billion market but is associated with significant toxicity and side effects.
Improving organ survival and reducing repeat transplants are key goals, as 11% of waitlisted adults need repeat procedures.
The market is highly concentrated, with 100 centers performing 80% of transplants, making it accessible for targeted commercialization.
Tegoprubart aims to address both the efficacy and safety limitations of current immunosuppressive therapies.
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