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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.
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
Posted In: ABBV
