Initial data from open label Phase 2a study expected in late 2022
IRVINE, CA, USA I May 09, 2022 I Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today reported that the first patient has been dosed in a Phase 2a study evaluating tegoprubart in patients with IgA Nephropathy (IgAN).
“There are over 150,000 Americans living with IgAN, and we believe tegoprubart has the potential to transform the current standard of care for people living with this disease,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are pleased to begin our clinical evaluation of tegoprubart in this area of great unmet need and look forward to sharing early results from this Phase 2a study at the end of the year.”
IgAN, the most common primary glomerulonephritis, is characterized by gradual, progressive kidney function deterioration which can potentially lead to End-Stage Renal Disease (“ESRD”), dialysis, renal transplant, and death. Leakage of blood proteins into the urine, or proteinuria, is a clinical sign of IgAN, and the severity of proteinuria predicts the rate of progression to ESRD. In addition, reducing proteinuria has been shown to delay progression to ESRD. Current standard of care with ACEi/ARB therapies and budesonide are effective in a subset of patients with IgAN but many patients will continue to have progressive disease and be at risk of ESRD.
This multicenter, open-label study is enrolling up to 21 patients in each of two dose cohorts with confirmed diagnosis of IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. The study will evaluate the safety and efficacy of tegoprubart, with the primary endpoint being change from baseline in urine protein after 24 weeks of therapy. Dosing will continue through 96 weeks, and change from baseline in eGFR slope will be assessed at 96 weeks. Preclinical evidence has demonstrated that blocking CD40L signaling can improve proteinuria, reduce autoantibodies, decrease immune cell infiltration into the kidneys, and improve survival.
About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop potential treatments for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with ALS. The company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
SOURCE: Eledon Pharmaceuticals
Post Views: 54
Initial data from open label Phase 2a study expected in late 2022
IRVINE, CA, USA I May 09, 2022 I Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today reported that the first patient has been dosed in a Phase 2a study evaluating tegoprubart in patients with IgA Nephropathy (IgAN).
“There are over 150,000 Americans living with IgAN, and we believe tegoprubart has the potential to transform the current standard of care for people living with this disease,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are pleased to begin our clinical evaluation of tegoprubart in this area of great unmet need and look forward to sharing early results from this Phase 2a study at the end of the year.”
IgAN, the most common primary glomerulonephritis, is characterized by gradual, progressive kidney function deterioration which can potentially lead to End-Stage Renal Disease (“ESRD”), dialysis, renal transplant, and death. Leakage of blood proteins into the urine, or proteinuria, is a clinical sign of IgAN, and the severity of proteinuria predicts the rate of progression to ESRD. In addition, reducing proteinuria has been shown to delay progression to ESRD. Current standard of care with ACEi/ARB therapies and budesonide are effective in a subset of patients with IgAN but many patients will continue to have progressive disease and be at risk of ESRD.
This multicenter, open-label study is enrolling up to 21 patients in each of two dose cohorts with confirmed diagnosis of IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. The study will evaluate the safety and efficacy of tegoprubart, with the primary endpoint being change from baseline in urine protein after 24 weeks of therapy. Dosing will continue through 96 weeks, and change from baseline in eGFR slope will be assessed at 96 weeks. Preclinical evidence has demonstrated that blocking CD40L signaling can improve proteinuria, reduce autoantibodies, decrease immune cell infiltration into the kidneys, and improve survival.
About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40 Ligand (CD40L, also called CD154) pathway to develop potential treatments for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with ALS. The company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
SOURCE: Eledon Pharmaceuticals
Post Views: 54
