Alphabet-founded research and development company Calico Life Sciences LLC announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track Designation for ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

An anti-PAPP-A human monoclonal antibody, ABBV-CLS-628 was developed by Calico in collaboration with AbbVie Inc (NYSE:ABBV). The therapy is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with ADPKD.

ABBV-CLS-628 has completed a Phase 1 study in healthy volunteers 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 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.