FDA Grants Orphan Drug Designation to Calico and AbbVie’s Investigational ADPKD Therapy

California, October 2025: Calico Life Sciences LLC (Calico), a biotechnology company founded by Alphabet Inc. and Arthur D. Levinson, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Developed in collaboration with AbbVie Inc., ABBV-CLS-628 is an anti-PAPP-A monoclonal antibody currently being evaluated in a Phase 2 clinical trial. The therapy previously received Fast Track Designation from the FDA.

Addressing an Urgent Unmet Need

“We are pleased that ABBV-CLS-628 has received both Fast Track and Orphan Drug designations, underscoring the urgent unmet need facing the ADPKD community,” said Arthur D. Levinson, Ph.D., CEO of Calico. “People living with this disease face a high risk of rapid disease progression, and we will continue to advance this program with the goal of improving treatment outcomes.”

ADPKD is the most common inherited kidney disorder worldwide, characterized by the growth of fluid-filled cysts in both kidneys. More than 50% of patients develop kidney failure by age 60, leaving dialysis or transplantation as the only treatment options.

About the Orphan Drug Designation

Established under the Orphan Drug Act of 1983, the ODD program supports the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S..
Benefits of this designation include tax credits for clinical testing, protocol assistance, seven years of market exclusivity, and waivers of certain FDA fees if the drug is approved.

About ABBV-CLS-628

ABBV-CLS-628 is a human monoclonal antibody designed to inhibit PAPP-A activity. It completed a Phase 1 study in healthy volunteers (ACTRN12622001550796), which showed that the drug was safe and well-tolerated with no significant adverse events.

The ongoing Phase 2 trial (NCT06902558) is enrolling participants across approximately 95 global sites. The double-blind study involves intravenous dosing every four weeks for 92 weeks, with an additional 15-week safety follow-up, and aims to assess safety, tolerability, and potential efficacy in slowing disease progression in ADPKD.

About Calico

Calico Life Sciences LLC, founded by Alphabet Inc., is dedicated to advancing research into the biology of aging and developing interventions to promote longer and healthier lives.

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