Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) stock is trading lower on Friday, with a session volume of 15.72 million, compared to its average volume of 1.24 million, according to Benzinga Pro. The company announced results from its Phase 2 BESTOW trial of tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant.
A “de novo” kidney transplant is a standard kidney transplant, but the term “de novo” refers to complications that develop after the transplant, not during the surgery itself.
In the trial, the company’s lead drug, tegoprubart, failed to offer significant improvements to estimated glomerular filtration rates (eGFR) in patients who had received a kidney transplant when compared with a standard of care (SoC) immunosuppressant, tacrolimus.
eGFR is a number calculated from a blood test that estimates how well the kidneys are filtering waste.
Tegoprubart demonstrated an eGFR of 69mL/min/1.73m² after 12 months of treatment, while patients on tacrolimus experienced a rate of 66mL/min/1.73m².
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Tegoprubart's impact on glomerular filtration was higher in living-related donor recipient patients, with the rate at 72mL/min/1.73m². High Kidney Donor Profile Index (KDPI > 35) transplant patients achieved 62mL/min/1.73m².
Eledon noted that, despite failure, tegoprubart delivered the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention.
Meanwhile, the composite endpoint of efficacy failure recorded for tegoprubart was non-inferior to tacrolimus, with 22% compared with 17% in the tacrolimus group.
Efficacy failure comprises death, graft loss, and biopsy-proven acute rejection.
The company says the results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability.
Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days). Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%).
Despite missing the primary efficacy endpoint, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements.
Estimated cash, cash equivalents, and short-term investments totaled approximately $93.4 million, which is expected to provide cash runway into late 2026.
Price Action: ELDN stock is down 59.03% at $1.68 at the last check on Friday.
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