CSL346 / CSL Behring - LARVOL DELTA

VEGF-B: A multifaceted modulator with emerging therapeutic applications. (PubMed, Pharmacol Res) - "However, clinical translation remains challenging, as exemplified by the recent failure of the anti-VEGF-B antibody CSL346 in diabetic kidney disease, underscoring our incomplete understanding of VEGF-B biology. This review integrates cutting-edge insights into the diverse functions of VEGF-B, proposes a mechanistic framework for its complex signaling networks, and outlines a roadmap for developing precision therapies for metabolic, cardiovascular, neurodegenerative, and oncological diseases. We address the critical translational challenges to maximize the therapeutic benefits while preserving the crucial homeostatic functions of VEGF-B."

Journal • Review • Cardiovascular • CNS Disorders • Diabetic Nephropathy • Heart Failure • Nephrology • Oncology • Renal Disease • FGFR1 • FLT1 • NRP1 • VEGFA • VEGFB

Vascular Endothelial Growth Factor (VEGF)-B Blockade with CSL346 in Diabetic Kidney Disease: A Phase 2A Randomized Controlled Trial. (PubMed, J Am Soc Nephrol) - P2 | "CSL346 did not reduce UACR compared with placebo at 16 weeks in participants with type 2 diabetes mellitus and DKD, and was associated with an increase in diastolic blood pressure."

Clinical • Journal • P2a data • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • VEGFB

Advancements in Diabetic Kidney Disease Management: Integrating Innovative Therapies and Targeted Drug Development. (PubMed, Am J Physiol Endocrinol Metab) - "Emerging agents including GLP-1 agonists, anti-inflammatory agents like bardoxolone, and mineralocorticoid receptor antagonists show promise in mitigating DKD progression. Many novel therapies including monoclonal antibodies CSL346, Lixudebart, and tozorakimab, mesenchymal stem/stromal cell infusion, and cannabinoid-1 receptor inverse agonism via INV-202 are currently in clinical trials and present opportunities for further drug development."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Hypertension • Immunology • Inflammation • Metabolic Disorders • Nephrology • Oncology • Renal Disease

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=114 | Completed | Sponsor: CSL Behring | Phase classification: P2a ➔ P2

Phase classification • Diabetic Nephropathy • Nephrology • Renal Disease

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2a | N=114 | Completed | Sponsor: CSL Behring | Recruiting ➔ Completed

Trial completion • Diabetic Nephropathy • Nephrology • Renal Disease

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2a; N=100; Recruiting; Sponsor: CSL Behring; Trial completion date: Feb 2022 ➔ Oct 2022; Trial primary completion date: Dec 2021 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2a; N=100; Recruiting; Sponsor: CSL Behring; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetic Nephropathy • Nephrology • Renal Disease

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2a; N=100; Not yet recruiting; Sponsor: CSL Behring

Clinical • New P2a trial • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease