Walden Biosciences Launches Key Initiatives To Advance Clinical Pipeline And Phase 2 Program For WAL0921 In Rare Kidney Diseases

Walden Biosciences, Inc., a privately held biotechnology company focused on developing disease-modifying therapies for kidney disease, has announced two important steps to advance its lead program, WAL0921. These initiatives are designed to support the ongoing Phase 2 clinical basket study of WAL0921 (WAL0921-02) for the treatment of rare chronic kidney diseases (CKDs). The company has engaged a highly regarded regulatory advisor and partnered with a patient-focused organization to enhance trial awareness and participation, further strengthening the path forward for the program.

WAL0921 is Walden’s proprietary, first-in-class humanized monoclonal antibody that targets soluble urokinase plasminogen activator receptor (suPAR). Elevated suPAR levels are known to trigger harmful pro-inflammatory signaling in podocytes, the specialized kidney cells essential for filtering blood. This leads to podocyte dysfunction, proteinuria, and ultimately kidney disease progression. By binding to and neutralizing suPAR, WAL0921 is designed to protect podocytes, reduce proteinuria, and slow or potentially halt disease progression in patients with rare CKDs.

Andrew Blair, M.D., Chief Medical Officer of Walden Biosciences, stated, “Dr. Stockbridge’s vast regulatory expertise and deep understanding of nephrology drug development bring tremendous value to Walden at this pivotal stage of our development. His insights will help ensure our clinical programs are designed and executed with the highest standards of scientific rigor and regulatory alignment, ultimately accelerating our mission to deliver innovative therapies to rare kidney disease patients with urgent unmet needs.”

Blaine McKee, Ph.D., Chief Executive Officer of Walden Biosciences, mentioned, “We are very pleased to be working with NephCure to advance our shared goal of transforming the treatment landscape for rare kidney disease patients. As the premier patient advocacy group supporting patients with rare kidney diseases, NephCure is ideally suited to enhance awareness of the potential of WAL0921 and our ongoing Phase 2 basket study. NephCure’s support in education, patient identification, and physician engagement offers the potential to enhance awareness and support recruitment of WAL0921-02 to advance development of this potentially transformative therapy for these patients. The ongoing Phase 2 clinical basket study is progressing to plan and on track to have initial interim data from the rare kidney disease patient Cohort in late 2025 and early in 2026.”

As part of its effort to advance clinical development, Walden has engaged Norman Stockbridge, M.D., Ph.D., Principal of S&S Consulting Partners LLC, as a regulatory and clinical advisor. Dr. Stockbridge previously served as Director of the Division of Cardiology and Nephrology at the U.S. Food and Drug Administration (FDA). With his extensive regulatory and clinical expertise, Dr. Stockbridge will provide Walden with strategic guidance on regulatory strategy, trial design, and overall clinical development planning across its nephrology pipeline. His insights are expected to help position WAL0921 for success as the company progresses through late-stage clinical development.

To complement these efforts, Walden has also partnered with NephCure, a nonprofit organization dedicated to supporting patients and families affected by rare, protein-spilling kidney diseases. Through this collaboration, Walden will gain access to NephCure’s patient outreach and clinical study matching services, which are intended to connect individuals living with proteinuria and rare kidney diseases to relevant clinical trial opportunities. This partnership is expected to expand awareness of Walden’s ongoing Phase 2 study and provide critical support for patient recruitment, a key factor in driving trial efficiency and timely execution.

Together, these initiatives highlight Walden Biosciences’ commitment to advancing WAL0921 as a potential first-in-class therapy to transform the treatment of chronic kidney diseases. By combining strong regulatory expertise with patient-centered engagement, the company is building a solid foundation to ensure the success of its clinical program and ultimately deliver meaningful therapies to patients in need.