Improving Kidney Transplant Longevity as Strategy in Managing Our National Organ Shortage

In the United States, around 25,000 people receive the life-saving gift of a kidney transplant every year. Yet, there's a stark contrast to this number: another 5,000 Americans die annually waiting for a transplant that never comes. It's a dramatic illustration of the critical shortage of organs. But what if we could make each transplanted kidney last longer? This isn't just about improving care for those who have received transplants; it's also about stretching the existing organ supply to save more lives.

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The challenge is that a transplanted kidney, while a modern medical miracle, has a limited lifespan. Each kidney comes with a silent clock, its tick-tock a reminder of the precious nature of the gift and the need to protect it. The drug tacrolimus is the guardian that protects most transplanted kidneys today. Although approved nearly thirty years ago in 1994, it remains the first-line, mainstay therapeutic to prevent organ rejection. But, as with all guardians, it has its weaknesses. Tacrolimus is considered toxic to the kidneys both directly as well as indirectly since it can help usher in diabetes and hypertension, ironically, the very conditions that lead most patients to require a transplant in the first place.

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However, within this complexity lies opportunity—an opportunity to innovate and to redefine care for transplant patients by developing new therapeutics that protect transplanted kidneys from rejection but that do not have tacrolimus’ side effects damaging the transplanted kidneys. In other words, ensuring that a kidney lasts as long as possible is no longer just about preventing rejection; it’s also about protecting transplanted organs from the potentially harmful side effects of their primary anti-rejection medication. Every transplant that doesn't fail due to tacrolimus related injury represents a potential opening for another patient on the waiting list. This means that improving kidney transplant longevity is not just a health issue for recipients—it's a critical strategy in managing the national organ shortage.

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Last week at the?American Society of Nephrology’s Kidney Week, our team at?Eledon Pharmaceuticals, Inc.?together with our principal investigators presented data from our Phase 1b study of #tegoprubart in kidney transplantation. Tegoprubart is more targeted than tacrolimus in that it designed to block CD40 Ligand (CD40L), a protein involved in immune system activation. As such, it has not demonstrated tacrolimus’ kidney toxicity. We reported that in the 11 patients enrolled in our study, starting at day 90, the patients on tegoprubart had kidney function (eGFR) at levels approximately 40% above the historical averages seen with tacrolimus, an eGFR outcome arguably unprecedented in a clinical trial. Moreover, the single patient that finished a year on drug to date - a 77 year woman with diabetes who had been on hemodialysis before her transplant - had an eGFR of 91 mL/min/1.73m2, approximately 80% above tracrolimus historicals and higher than what would typically be expected in a woman her age without diabetes and with two native working kidneys!

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We believe that these data bring us closer to the cusp of a new epoch in transplant medicine—an era where the organ donor shortage is alleviated not only by greater donor generosity but also by ensuring that each donated kidney can serve its recipient longer and better. We press forward and keep our eye towards our mission, giving every kidney gifted the chance to beat the clock and bringing forth the day where every patient may have “One Transplant for Life.”

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Link to related PR & Forward-Looking Statement info: https://ir.eledon.com/news-releases/news-release-details/eledon-reports-updated-data-ongoing-phase-1b-trial-evaluating

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Link to related data presentation: https://ir.eledon.com/static-files/7e6b272f-ccbf-44ec-9f12-0a51ec733f19