The Challenges for Organ Transplant Recipients
A transplant is a new beginning—but it comes with a lifelong commitment. To keep the body from rejecting a new organ, recipients must take immunosuppressant medications for the rest of their lives. These drugs are essential, but over time they can take a serious toll, including damage to the transplanted organ itself. That damage is a leading cause of graft failure: for example, most kidney transplant recipients lose their new kidney within about 10 to 15 years, often sending them back to dialysis or onto the waiting list for another transplant.
Eledon is working to change that. We’re developing tegoprubart, an investigational therapy designed to support more durable transplants with fewer medication-related side effects. We believe that meaningfully extending the life of a transplanted organ could reduce the need for repeat transplants, make more organs available to more people, shorten waiting times, and improve quality of life for patients—and our clinical trials are how we put that goal to the test.
Tegoprubart Clinical Development
Eledon has completed BESTOW, a global Phase 2 clinical trial evaluating tegoprubart for the prevention of kidney transplant rejection in first-time allograft recipients. Participants completing BESTOW were eligible to enroll in an ongoing global open-label extension study to evaluate the long-term efficacy and safety of tegoprubart.
In parallel, Eledon is conducting an ongoing single-arm Phase 1b clinical trial of tegoprubart for the prevention of rejection in persons receiving a kidney transplant. Eledon is also currently evaluating tegoprubart’s potential in other types of organ transplantation, including islet cell transplantation, liver transplantation and xenotransplantation.
Eledon never charges patients to participate in our clinical trials.
Participation in Eledon-sponsored or Eledon-supported clinical trials is always free. Eledon, and the hospitals, physicians, investigators, and study staff involved in our clinical trials, will never ask you or your family to pay money to enroll in a trial, “reserve a spot,” be considered for participation, or secure access to treatment.
Enrollment in an Eledon clinical trial is handled solely through official clinical trial sites and authorized study staff, and only using professional email addresses. Legitimate trial information, including participating locations and site contacts, can be found on ClinicalTrials.gov.
Anyone who requests payment, gift cards, bank information, wire transfers, cryptocurrency, or any other form of compensation as a condition of participating in an Eledon clinical trial — or who claims that payment will guarantee or improve your chances of enrollment — is not acting on behalf of Eledon.
If you are contacted by someone making these claims: do not send money or provide financial information, and immediately contact Eledon at info@eledon.com.
Expanded Access Policy for Tegoprubart in Adult Kidney Transplant Patients
Eledon Pharmaceuticals, Inc. is committed to developing investigational therapies for patients with serious medical conditions through clinical trials, with the goal of supporting potential regulatory approval and broader patient access if approved.
Tegoprubart, also known as AT-1501, is an investigational therapy being evaluated by Eledon for the prevention of organ rejection in kidney transplant recipients. The U.S. Food and Drug Administration has granted Fast Track designation to tegoprubart for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Following FDA’s grant of Fast Track designation, Eledon is making this expanded access policy publicly available in accordance with section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-0.
Expanded access, also known as “compassionate use,” may provide a pathway for eligible patients with a serious or immediately life-threatening disease or condition to receive an investigational therapy outside of a clinical trial when no comparable or satisfactory alternative therapy options are available.
Eledon may consider expanded access requests for tegoprubart on a case-by-case basis for adult patients receiving a kidney transplant. Requests must be submitted by the patient’s licensed treating physician. Eledon will consider several factors, including whether the patient is eligible for or able to participate in an applicable clinical trial, availability of comparable or satisfactory alternative therapies, potential benefit-risk, drug supply, ability to comply with applicable regulatory requirements, and potential impact on ongoing or planned clinical trials and development programs.
Treating physicians may contact Eledon at EAP@eledon.com. Eledon generally will acknowledge receipt of a complete request within 7 business days.
Tegoprubart is investigational and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for the prophylaxis of organ rejection in kidney transplant recipients. The posting of this policy does not guarantee access to tegoprubart, and Eledon may revise this policy at any time.
Clinical Trial Information
Information regarding our active clinical trials can be found at Home | ClinicalTrials.gov.