The Challenges for Kidney Transplant Recipients

There are about 100,000 people in the United States currently waiting for a kidney transplant. Most patients with end-stage renal disease who are seeking a new kidney face serious health challenges both pre- and post-surgery. Before the transplant, patients may suffer from the debilitating symptoms associated with end-stage renal disease. Securing a donor kidney, either from a living or deceased donor, is a significant hurdle that often requires navigating a difficult process and a waiting period that can last years.

While waiting for an organ to be available, people eligible for a kidney transplant typically undergo dialysis, which artificially performs essential and life-saving kidney functions. Dialysis is often costly, involving multiple sessions a week over several hours, various surgeries, physical discomfort and a risk of long-term complications including heart disease.

Post-kidney transplant, recipients must adapt to a lifelong regimen of immunosuppressant medications to reduce the risk of organ rejection. These drugs present a risk of serious side effects including drug-related damage to the kidney itself, diabetes, and hypertension, leading the drugs themselves to be a leading cause of kidney graft failure. As a result, most kidney transplant patients experience organ failure within about 10-12 years, requiring them to return to treatment with dialysis or have one or more additional transplants during their lifetime.

Eledon is developing tegoprubart to tackle the challenge for more durable kidney transplants with fewer medicine related side effects. We believe that measurably increasing the lifespan of transplanted kidneys would decrease the needs for repeat transplant, increase the number of kidneys available for transplant, decrease the duration of dialysis and waiting times for a kidney, and increase the quality of life for patients.

The BESTOW Clinical Trial

We are currently advancing BESTOW, a Phase 2 clinical trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney allograft for the first time. BESTOW is a multicenter, two-arm, active comparator, clinical trial evaluating the safety and efficacy of tegoprubart compared with the current standard of care. The trial’s primary endpoint is superiority in kidney function as measured by mean estimated glomerular filtration rate (eGFR) at one-year post-transplantation in participants receiving tegoprubart versus tacrolimus. Secondary objectives include safety, incidence of new onset diabetes, biopsy-proven rejection, and graft survival. The trial will enroll approximately 120 participants (60/arm) undergoing kidney transplant and will run in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation.

Participants in the BESTOW trial will be eligible to enroll in an open-label extension trial allowing for the collection of long-term tegoprubart efficacy and safety data.