Calico Life Sciences Receives FDA Fast Track Designation for ADPKD Treatment
Calico Life Sciences LLC, a biotechnology company founded by Alphabet Inc., announced on October 2, 2025 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ABBV-CLS-628, an investigational therapy targeting autosomal dominant polycystic kidney disease (ADPKD).
Disease Background
ADPKD is the most common inherited kidney disorder worldwide. The progressive genetic condition is characterized by fluid-filled cyst development in both kidneys, ultimately leading to kidney failure in more than 50% of patients by age 60. Currently, patients have limited treatment options, with dialysis or kidney transplantation being the primary interventions once kidney function significantly declines.
Drug Mechanism and Development
ABBV-CLS-628 is a human monoclonal antibody designed to inhibit pregnancy-associated plasma protein-A (PAPP-A) activity. Developed through a collaboration between Calico and AbbVie Inc., the investigational therapy aims to slow kidney function decline in patients with high-risk ADPKD progression.
Clinical Development Status
The drug is currently in a Phase 2 clinical trial (NCT06902558) enrolling approximately 95 sites globally. Key trial details include:
- Intravenous administration every 4 weeks
- 92-week treatment duration
- Safety and efficacy evaluation
- Participants receiving either ABBV-CLS-628 or placebo
A previous Phase 1 study in healthy volunteers demonstrated the drug's safety and tolerability, with no significant adverse events reported.