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

UPDATED: AbbVie to end Calico collab after 11-year run, plans layoffs: Stat (FierceBiotech) - "The changes come as North Chicago-based AbbVie pivots away from small molecules in favor of injectables and genetic medicines, according to the email cited by Stat...Central to the partnership was fosigotifator, an amyotrophic lateral sclerosis asset designed to target eIF2B....Additionally, the pair were working on an investigational monoclonal antibody dubbed ABBV-CLS-628."

Commercial • Amyotrophic Lateral Sclerosis • Major Depressive Disorder • Polycystic Kidney Disease

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