Abstract: INFO15-FR
Trial in Progress: ANCHOR, a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-CLS-628 in ADPKD
Session Information
- Informational Posters - 2
October 23, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Genetic Diseases of the Kidneys
- No subcategory defined
Authors
- Perrone, Ronald D., Tufts Medical Center, Boston, Massachusetts, United States
- Koukos, Georgios, Calico Life Sciences LLC, South San Francisco, California, United States
- Samant, Meghna, Calico Life Sciences LLC, South San Francisco, California, United States
- Horton, Maureen R., Calico Life Sciences LLC, South San Francisco, California, United States
Description
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by progressive cyst growth and declining renal function, representing a leading cause of end-stage renal disease (ESRD). Current therapeutic options remain limited.
Pregnancy-associated plasma protein-A (PAPP-A) is a metalloproteinase that cleaves insulin-like growth factor (IGF)-binding proteins (IGFBP), thereby increasing local IGF bioavailability. In mouse models of ADPKD, genetic deletion or monoclonal antibody inhibition of PAPP-A significantly mitigates total kidney volume (TKV) growth, preserves eGFR, and prolongs survival.
ABBV-CLS-628 is a novel, fully human IgG1 monoclonal antibody designed to neutralize PAPP-A proteolytic activity and reduce local IGF signaling. Following demonstration of a favorable tolerability profile in healthy volunteers, a Phase 2 study was initiated to evaluate the efficacy and safety of ABBV-CLS-628 in patients with ADPKD.
ANCHOR (NCT06902558) is an ongoing, global, Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial that will randomize 240 participants 1:1:1:1 into four parallel arms (placebo or 1 of 3 doses of ABBV-CLS-628) administered intravenously every 4 weeks for a 96-week treatment period, followed by a 15-week safety follow-up. Key inclusion criteria include adults aged 18–55 years with a confirmed diagnosis of ADPKD (Mayo Clinic Imaging Classification 1C, 1D, or 1E) and baseline eGFR ≥ 30 to < 90 mL/min/1.73 m2. Main exclusion criteria include current interventions targeting ADPKD or other confounding medical conditions. The primary endpoint is safety and the cumulative rate of change from baseline TKV measured by MRI at Week 96. Key secondary endpoints include absolute change in eGFR from baseline at Weeks 48 and 96, and time to clinical progression to ESRD.
The ANCHOR trial is actively recruiting participants across 72 clinical sites in 12 countries spanning North America, Europe, and the InterContinental/East Asia regions. No clinical efficacy data are yet available.
ANCHOR is the first global Phase 2 study targeting the PAPP-A/IGF signaling pathway in ADPKD. By neutralizing local IGF bioavailability, ABBV-CLS-628 represents a novel therapeutic mechanism with the potential to slow cyst expansion and delay disease progression in high-risk patients.
Funding
- Calico Life Sciences LLC