Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting

Core Insights - Eledon Pharmaceuticals announced positive results from its Phase 2 BESTOW trial for tegoprubart, showing its potential as a new standard for preventing kidney transplant rejection [2][3] - Tegoprubart demonstrated a favorable safety profile, significantly reducing common toxicities associated with tacrolimus, including metabolic, neurologic, and cardiovascular issues [3][6] - The company plans to advance tegoprubart into Phase 3 development following discussions with regulators [8] Study Design - The Phase 2 BESTOW trial was a 12-month, randomized, head-to-head study involving 127 kidney transplant recipients, comparing tegoprubart with tacrolimus [4] - All participants received rabbit antithymocyte globulin induction and maintenance therapy with mycophenolate mofetil and corticosteroids [4] Efficacy Results - The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months post-transplant, with tegoprubart achieving a mean eGFR of 69 mL/min/1.73 m² compared to 66 mL/min/1.73 m² for tacrolimus [12] - The efficacy failure composite endpoint was 22% for tegoprubart versus 17% for tacrolimus, demonstrating non-inferiority for tegoprubart [12] - Subgroup analyses indicated higher eGFRs for tegoprubart in nearly all categories, particularly among living-related donor recipients [12] Safety Results - Tegoprubart showed a significantly lower incidence of new-onset diabetes (1 in 47) compared to tacrolimus (1 in 6) [6] - Neurologic effects such as tremor were markedly lower in the tegoprubart group (1.6% vs. 25.0%) [6] - Cardiovascular issues, including hypertension and heart failure, were also less prevalent in the tegoprubart group [6] Next Steps - Eledon plans to incorporate insights from the Phase 2 data and ongoing studies to optimize the Phase 3 protocol [8] - The company is preparing for discussions with regulators regarding study design and data requirements for the next phase [8] Financial Position - As of September 30, 2025, Eledon reported approximately $93.4 million in cash, cash equivalents, and short-term investments, expected to fund operations until late 2026 [9]