Calico Life Sciences LLC announced that the U.S. Food and Drug Administration has granted Fast Track Designation for ABBV-CLS-628, an investigational monoclonal antibody therapy for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The therapy, developed through a collaboration between Calico and AbbVie Inc., is currently undergoing Phase 2 clinical evaluation.
"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."
Addressing a Critical Unmet Need
ADPKD represents the most common inherited kidney disease worldwide. The progressive condition is characterized by the development and growth of fluid-filled cysts in both kidneys, ultimately leading to kidney failure in more than 50% of patients by age 60. At that advanced stage, dialysis or kidney transplantation become the only available treatment options.
Fast Track Designation is an FDA process specifically designed to facilitate development and expedite review of drugs treating serious conditions with unmet medical needs. This regulatory pathway provides sponsors with enhanced communication and collaboration opportunities with the FDA, enabling faster resolution of questions and issues while potentially accelerating patient access to important new therapies.
Novel Therapeutic Mechanism
ABBV-CLS-628 is an investigational human monoclonal antibody designed to inhibit PAPP-A (Pregnancy-Associated Plasma Protein-A) activity. The therapy has successfully completed a Phase 1 study in healthy volunteers (ACTRN12622001550796), demonstrating safety and tolerability with no significant adverse events reported to be associated with the drug.
Global Phase 2 Trial Underway
The ongoing Phase 2 study (NCT06902558) is currently enrolling participants across approximately 95 sites globally. The trial design involves participants receiving intravenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks, followed by safety follow-up for up to 15 weeks. The study is specifically designed to evaluate the safety, tolerability, and potential efficacy of ABBV-CLS-628 in slowing disease progression in ADPKD patients.
This regulatory milestone represents a significant step forward for patients with ADPKD, a condition with limited therapeutic options and substantial clinical impact. The Fast Track Designation underscores the FDA's recognition of both the serious nature of ADPKD and the potential therapeutic value of targeting the PAPP-A pathway in this patient population.
