ABBV-CLS-628 / AbbVie, Calico Life Sciences - LARVOL DELTA

A novel monoclonal antibody against PAPP-A significantly inhibits disease progression in three mouse models of autosomal dominant polycystic kidney disease (ERA 2025) - "ABBV-CLS-628 is a novel human monoclonal antibody that acts as a specific and potent inhibitor of PAPP-A. Treatment with anti-PAPP-A provided a significant benefit in clinically relevant endpoints (TKV and GFR) and modulated disease relevant pathways, in three different mouse models of ADPKD. ABBV-CLS-628 is under clinical development for the treatment of ADPKD."

Preclinical • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease • IGFBP2 • IGFBP5 • TGFB1

Safety and Tolerability of ABBV-CLS-628: Results From a Phase 1 First-in-Human Study (ERA 2025) - P1 | "ABBV-CLS-628 was safe and well tolerated in healthy adults in this phase 1 study. Overall, these results support further investigation in a larger study."

Clinical • P1 data • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease