Calico Life Sciences Announces U.S. FDA Fast Track Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease

SOUTH SAN FRANCISCO, Calif., Oct. 2, 2025 /PRNewswire/ -- Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today 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). ABBV-CLS-628, an anti-PAPP-A monoclonal antibody, was developed by Calico in collaboration with AbbVie Inc. The therapy is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with ADPKD. 

"We are pleased that ABBV-CLS-628 has been granted Fast Track Designation," said Arthur D. Levinson, Ph.D., CEO of Calico. "This recognition reflects the significant unmet need facing the ADPKD community and the potential of ABBV-CLS-628 to slow kidney function decline in patients with a high risk of rapidly progressing disease. With limited treatment options available, we are hopeful that this therapy may ultimately provide patients with much-needed treatment options."

ADPKD is the most common inherited kidney disease worldwide.¹ Characterized by the development and growth of fluid-filled cysts in both kidneys, the progressive disease leads to kidney failure in more than 50% of patients by age 60. At that stage, dialysis or a transplant are the only treatment options.²

Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This status provides sponsors with increased communication and collaboration from the FDA regarding their drug candidate to address questions and issues quickly, with the potential of getting important new therapies to the patient earlier.³

About ABBV-CLS-628
ABBV-CLS-628, an investigational human monoclonal antibody designed to inhibit PAPP-A activity, is being evaluated for the treatment of ADPKD. 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. This study is designed to evaluate the safety, tolerability, and potential efficacy of ABBV-CLS-628 in slowing disease progression in ADPKD.

About Calico
Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. To learn more about Calico, visit www.calicolabs.com. Follow @calico on LinkedIn, X (formally Twitter), and YouTube.

References
1 - NIH NIDDK (2025, September 28)
2 - National Kidney Foundation (2025, September 28)
3 - Fast Track | FDA (2025, September 28)

SOURCE Calico