Calico's Kidney Disease Bet: New Therapy Gains Fast Track for Polycystic Kidney Disease

SAN FRANCISCO, CA – November 6, 2025 – Alphabet-founded research and development company Calico Life Sciences, traditionally focused on aging and age-related diseases, is venturing into new territory with a promising investigational therapy for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The U.S. Food and Drug Administration (FDA) has granted both Fast Track and Orphan Drug designations to ABBV-CLS-628, a novel anti-PAPP-A monoclonal antibody developed in collaboration with AbbVie Inc., signaling a potential turning point for those affected by this debilitating genetic condition.

ADPKD, the most common inherited kidney disease, affects an estimated hundreds of thousands in the United States. Characterized by the growth of fluid-filled cysts in the kidneys, the progressive nature of the disease often leads to kidney failure, requiring dialysis or transplant in over half of patients by age 60. While treatments like tolvaptan exist, they are not without limitations and don’t halt disease progression for all. “The current standard of care provides some relief, but many patients still face a steep decline in kidney function,” explained one nephrologist familiar with the condition. “There’s a clear need for more effective therapies.”

A Novel Approach Targeting PAPP-A

ABBV-CLS-628 represents a shift in treatment strategy. Unlike existing therapies that primarily focus on managing symptoms, this antibody targets PAPP-A, a protein increasingly implicated in the development and progression of ADPKD. Research suggests PAPP-A plays a role in cell growth and proliferation, pathways disrupted in cyst formation. “Blocking PAPP-A could potentially slow down cyst growth and preserve kidney function for a longer period,” stated a researcher studying the molecular mechanisms of ADPKD. “The pre-clinical data is compelling, and the clinical trials will be crucial in confirming these findings.”

The FDA's Fast Track designation streamlines the development and review process for therapies addressing unmet medical needs, and the Orphan Drug designation provides incentives for developing treatments for rare diseases like ADPKD. Currently, a Phase 2 clinical trial is underway, enrolling 120 participants across approximately 95 sites globally. The double-blind, randomized study is designed to assess the safety and efficacy of ABBV-CLS-628 in slowing disease progression. Results are anticipated in late 2025/early 2026.

Calico's Expanding Horizons

While best known for its research into the biology of aging, Calico’s expansion into kidney disease demonstrates a broadening of its scientific focus. “Calico is built on the principle of applying innovative research to tackle challenging diseases,” explained an industry analyst familiar with the company’s strategy. “ADPKD presents a significant unmet need, and this collaboration with AbbVie allows Calico to leverage its expertise in antibody development and translational research.”

The partnership with AbbVie is also a key element of Calico’s approach. AbbVie brings significant experience in drug development, manufacturing, and commercialization. This synergistic relationship allows Calico to focus on early-stage research and discovery while AbbVie handles the later stages of development and potential market launch.

Competitive Landscape & Future Outlook

The ADPKD treatment landscape is evolving, with several companies actively pursuing novel therapies. Janssen and Otsuka are among the key players developing competing compounds. However, ABBV-CLS-628’s unique mechanism of action – targeting PAPP-A – differentiates it from existing and emerging treatments. “The competition is healthy,” said a patient advocate involved in the Polycystic Kidney Disease Foundation. “More options mean more hope for patients. We’re eager to see the results of the clinical trials and understand how this new therapy could improve the quality of life for those living with ADPKD.”

The road to market is still long, and success is not guaranteed. However, the FDA designations, coupled with the strong scientific rationale behind ABBV-CLS-628, suggest a promising future for this investigational therapy. The coming years will be critical in determining whether Calico’s bet on a novel approach to treating ADPKD will pay off, potentially offering a new lease on life for thousands of patients worldwide. “There’s a lot of excitement within the medical community about this approach,” remarked one nephrologist. “If the clinical trials are successful, this could really change the game for ADPKD patients.”

Key Takeaways:

• Novel Mechanism: ABBV-CLS-628 targets PAPP-A, a protein linked to ADPKD progression, offering a new therapeutic approach.
• FDA Support: Fast Track and Orphan Drug designations expedite development and offer incentives.
• Expanding Focus: Calico broadens its research beyond aging, demonstrating a commitment to tackling challenging diseases.
• Competitive Landscape: Several companies are developing ADPKD therapies, creating a dynamic and evolving treatment landscape.
• Patient Hope: The development of ABBV-CLS-628 offers renewed hope for those living with ADPKD and their families.