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 have completed BESTOW, a global Phase 2 clinical trial evaluating tegoprubart for the prevention of kidney transplant rejection in first-time allograft recipients. BESTOW was a multicenter, active-comparator study designed to assess the safety and efficacy of tegoprubart versus tacrolimus, the current standard of care. The primary endpoint was safety as well as kidney function, measured by mean estimated glomerular filtration rate (eGFR) at 12 months post-transplant. Secondary endpoints included patient and graft survival, incidence of new-onset diabetes, biopsy-proven acute rejection, and delayed graft function. Participants completing BESTOW are eligible to enroll in an ongoing global open-label extension study to evaluate the long-term efficacy and safety of tegoprubart.
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