What’s Happening?
A new Breakthrough T1D-funded clinical trial investigating Eledon Pharmeceuticals’ immunotherapy, tegoprubart, with islet cell transplants in people with type 1 diabetes (T1D) and chronic kidney disease (CKD) just launched! This is the first time people with T1D and reduced kidney function are eligible for an islet cell therapy clinical trial—and the first person enrolled has received their transplant.
Tegoprubart and T1D: How We Got Here
Standard immunosuppressants can come with several side effects, including toxicity to the kidneys and damage to the transplanted islet cells themselves. Because of this, standard immunosuppression approaches, especially those that include tacrolimus, are not suitable for everyone who needs an islet transplant. Tegoprubart is a targeted immune therapy that offers a solution by acting as a milder, more targeted alternative—it can prevent rejection of transplanted islets with fewer side effects.
Eledon is currently running a Breakthrough T1D-funded clinical trial testing tegoprubart with deceased-donor islet cell transplants in people with severe hypoglycemic events or hypoglycemia unawareness. In this trial, all 12 participants are off injected insulin—with no side effects (and 3 additional people are enrolled). We know that this approach can be a functional cure for T1D. Now, Eledon is pursuing the next step: expanding access to people with T1D and CKD.
A New Clinical Trial and Another Step Forward
Immunosuppression is a barrier to eligibility for islet cell therapies. Because of the potential for kidney toxicity, people with T1D and CKD have been excluded from islet transplant studies if their kidney function is too low. Because CKD is common in people with T1D, this has been one of the biggest roadblocks for this population to access potential cures.
T1D and Chronic Kidney Disease
Nearly one third of people with living with T1D develop kidney disease, which increases the risk of kidney failure and heart disease. Finerenone (brand name Kerendia) is the first therapy in three decades to be approved to slow progression of kidney disease in people with T1D and CKD. Yet, treatment options remain limited—and Breakthrough T1D is investing in research to accelerate more therapies for this population.
Until now, islet cell transplants were limited to people with T1D and healthy kidney function. Now that we have an option to replace toxic immunosuppression with milder tegoprubart, people with T1D and CKD are eligible for an islet cell therapy clinical trial for the first time ever. If this trial succeeds, islet cell transplants would be open to a larger portion of the T1D population.
Get Involved
This is a multi-center clinical trial that’s currently enrolling up to 10 participants at the University of Chicago and the University of Miami. Participants will receive tegoprubart in addition to a calcineurin inhibitor-free immunosuppression regimen (meaning no tacrolimus, which can be toxic to kidneys).
One year post-transplant, the investigators will measure the number of participants who have achieved insulin therapy independence, HbA1c levels less than 7%, and no severe hypoglycemic episodes, as assessed by continuous glucose monitoring (CGM).
Key eligibility criteria:
- Between 18-70 years old
- Diagnosed with T1D for more than 5 years, with onset having occurred at less than 40 years of age
- Chronic kidney disease in stage 1, 2, or 3a
- Impaired awareness of hypoglycemia
Our Role and What’s Next
To make this new clinical trial possible, Breakthrough T1D awarded $8.5 million to the University of Chicago to fund the study, and Eledon is also a T1D Fund portfolio company. We are following this trial closely, and we look forward to seeing how the first person who received their transplant will progress.
“Advancing promising islet cell research that is a next step toward durable and scalable cures for type 1 diabetes is a key priority for Breakthrough T1D. We’re proud to support this trial that expands cell therapy research and access to people living with T1D and chronic kidney disease for the first time.” – Esther Latres, Ph.D., Senior Vice President of Research at Breakthrough T1D
This trial is a key step forward in Breakthrough T1D’s Project ACT initiative and our larger goal of expanding access to islet cell therapies. The end game is little to no immunosuppression needed so that anyone with T1D, regardless of other complications, can get an islet cell transplant if they want to. We previously published a roadmap for how we can get islet cell therapies to more people—and this clinical trial will help us get there.
Key Takeaways
- The first person in the new Breakthrough T1D-funded clinical trial testing Eledon’s tegoprubart in people with T1D and CKD has received their islet transplant.
- This is the first clinical trial that is expanding islet cell transplants to people with T1D who have reduced kidney function.
- Breakthrough T1D invested $8.5M to fund this trial as a major step toward expanding the eligible T1D population for islet cell therapies, regardless of complications.
