Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for people requiring an organ or cellular transplant, and for people living with autoimmune and neurodegenerative disease. The firm’s compound in development is AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. The CD40L/CD40 pathway is recognized for its prominent role in immune regulation, making it a candidate for therapeutic intervention in transplant tolerance, autoimmune disease, and neuro-inflammation. The company is building upon a deep historical understanding of the CD40/CD40L pathway, as well as preclinical and Phase 1 data, to initiate up to four phase 2 clinical studies with AT-1501. Eledon Pharmaceuticals was founded on March 26, 2004 and is headquartered in Irvine, CA.
相关临床试验
11
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2004
进行中（未招募）
2
18.2%
已完成
1
9.1%
尚未招募
1
9.1%
招募中
4
36.4%
终止
1
9.1%
Unknown
1
9.1%
撤回
1
9.1%
暂无批准数据
- Eledon Pharmaceuticals' Phase 2 BESTOW trial demonstrated tegoprubart's favorable safety profile in kidney transplantation, reducing metabolic, neurologic, and cardiovascular toxicities associated with standard tacrolimus therapy. - The anti-CD40L antibody achieved a mean eGFR of 69 mL/min/1.73 m² at 12 months, which the company believes is the highest reported in larger kidney transplant rejection prevention trials. - All six type 1 diabetes patients treated with tegoprubart following islet transplantation achieved insulin independence, with the first three remaining insulin-free for over one year. - The company secured $57.5 million in financing to support operations through Q2 2027 and plans to initiate Phase 3 trials pending FDA guidance.
- Eledon Pharmaceuticals' tegoprubart failed to demonstrate statistical superiority over tacrolimus in preventing kidney transplant rejection but achieved the highest mean eGFR levels reported in kidney transplant clinical trials. - The drug met non-inferiority criteria with a 22% efficacy failure rate compared to 17% for tacrolimus, satisfying FDA's recognized approval endpoint for transplant rejection prevention. - Despite the primary endpoint miss, Eledon plans to advance tegoprubart into Phase III development based on encouraging kidney function preservation data from the BESTOW trial. - Company shares dropped 59% following the mixed Phase II results announcement at the American Society of Nephrology's Kidney Week in Houston.
- Atacicept demonstrated a 45.7% reduction in proteinuria and 41.8-point placebo-adjusted advantage in the phase 3 ORIGIN 3 trial for IgA nephropathy, marking significant progress in targeted B-cell modulation therapy. - Finerenone achieved a 25% relative reduction in urinary albumin-to-creatinine ratio in type 1 diabetes patients with chronic kidney disease, representing the first new therapeutic option for this population in nearly 30 years. - Fish oil supplementation reduced serious cardiovascular events by 43% in maintenance hemodialysis patients, offering a simple intervention with substantial clinical impact for this high-risk population. - Multiple novel therapies including MIL62, povetacicept, and telitacicept showed promising results in glomerular diseases, highlighting the field's shift toward precision medicine and disease-modifying treatments.
- Eledon Pharmaceuticals will present updated clinical data from approximately 30 kidney transplant recipients in their ongoing Phase 1b study of tegoprubart at the World Transplant Congress in San Francisco. - The anti-CD40L antibody tegoprubart is being developed for kidney transplant rejection prevention and will be featured in an oral presentation by Dr. John Gill from the University of British Columbia. - Additional preclinical data will showcase tegoprubart's potential in liver transplantation using non-human primate models, indicating expanded therapeutic applications beyond kidney transplantation. - The company will sponsor a satellite symposium exploring long-term transplant success metrics, positioning tegoprubart in the context of lasting graft function rather than just short-term rejection prevention.
- Sernova Biotherapeutics and Eledon Pharmaceuticals announced a collaboration to evaluate tegoprubart, an anti-CD40L antibody, in Sernova's Phase 1/2 Cell Pouch Bio-hybrid Organ clinical trial for type 1 diabetes. - Tegoprubart will replace tacrolimus in Cohort C of the trial, potentially offering superior islet cell protection with reduced toxicity compared to standard immunosuppression. - Previous study results showed three patients achieved insulin independence with tegoprubart, demonstrating islet engraftment three to five times higher than tacrolimus-based treatments. - The partnership combines Sernova's retrievable Cell Pouch technology with Evotec's stem cell-derived islet clusters and Eledon's novel immunosuppressive approach to advance a potential functional cure for type 1 diabetes.
- Massachusetts General Hospital successfully performed its second pig-to-human kidney transplant using Eledon's tegoprubart as a key immunosuppressant, with the patient now off dialysis after two years. - Tegoprubart, an anti-CD40L antibody, demonstrates potential in preventing organ rejection by blocking multiple costimulatory receptors, marking a significant advancement in xenotransplantation. - The procedure, performed on January 25, 2025, represents a crucial milestone in addressing the global organ shortage crisis, with MGH planning two additional xenotransplants this year.
- Eledon Pharmaceuticals completed Phase 2 BESTOW trial enrollment for tegoprubart in kidney transplantation, with topline results expected in Q4 2025. - Updated Phase 1b data supports tegoprubart's safety and tolerability in preventing kidney transplant rejection, showing stable eGFR in patients. - Initial data from a UChicago Medicine trial indicates tegoprubart may enable insulin independence in type 1 diabetes patients post-islet transplantation. - Eledon secured $135 million in financing, expected to sustain operations through 2026, supporting ongoing clinical development of tegoprubart.
- Initial data from a University of Chicago study show that tegoprubart, an anti-CD40L antibody, helped two out of three patients achieve insulin independence after islet transplantation. - Islet engraftment was three to five times higher in patients treated with tegoprubart compared to those receiving standard tacrolimus-based immunosuppression. - Tegoprubart was generally well-tolerated, with no unexpected adverse events or severe hypoglycemic episodes reported during the study. - These findings suggest tegoprubart's potential as a novel immunosuppressant to improve islet transplantation outcomes for individuals with type 1 diabetes.
- Tegoprubart, an experimental immunosuppressant, demonstrates encouraging results in islet cell transplants for Type 1 diabetes, potentially reducing or eliminating the need for insulin injections. - In a study of three patients, two achieved insulin independence and normal A1C levels after tegoprubart treatment, while the third significantly reduced insulin needs. - Tegoprubart shows improved islet cell engraftment and reduced toxicity compared to the standard immunosuppressant tacrolimus, offering a potentially safer and more effective option. - Eledon is continuing to study tegoprubart in clinical trials to assess its safety and efficacy in kidney transplants, animal organ transplants, and ALS.
- Marlaina Goedel, a 30-year-old woman from Illinois, has been cured of type 1 diabetes after 25 years of insulin dependence through a pioneering islet cell transplant. - The experimental therapy involves transplanting islet cells into the liver, enabling the body to produce insulin independently, with Goedel ceasing insulin injections within four weeks. - The clinical trial utilized tegoprubart, an experimental drug that prevents immune system rejection of transplanted cells, showing promising results in stabilizing blood sugar levels. - Researchers are optimistic about the potential for functional cures in type 1 diabetes, with plans for additional trials to expand the treatment's availability.
