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

Calico Life Sciences Announces U.S. FDA Orphan Drug Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease (PRNewswire)

Orphan drug • Autosomal Dominant Polycystic Kidney Disease

FDA Grants Fast Track Designation to Investigational Anti–PAPP-A Antibody for ADPKD (DocWire)

Fast track • Autosomal Dominant Polycystic Kidney Disease

Calico Life Sciences LLC…announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). (PRNewswire) - "ABBV-CLS-628 has completed a Phase 1 study in healthy volunteers (ACTRN12622001550796) in which it was shown to be safe and well tolerated with no significant adverse events reported to be associated with the drug...The ongoing Phase 2 study (NCT06902558) is now enrolling across approximately 95 sites globally. Participants receive intravenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks, with safety follow-up for up to 15 weeks."

Fast track • Autosomal Dominant Polycystic Kidney 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 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

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