Walden Biosciences Announces Key Initiatives to Advance Clinical Pipeline and Support Phase 2 Program for WAL0921 in Rare Kidney Diseases
Engages Former FDA Director of Division of Cardiology and Nephrology, Norman Stockbridge, M.D., Ph.D., to Advise on Walden’s Clinical Pipeline in Rare Kidney Diseases
Utilizes Rare Kidney Disease Patient Advocacy Group to Broaden Awareness and Outreach Services
CAMBRIDGE, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private biotechnology company advancing disease modifying therapies to transform the treatment of kidney disease, today announced two key initiatives to support the WAL0921 development program, including the ongoing Phase 2 clinical basket study of WAL0921 (WAL0921-02), as a treatment for rare chronic kidney diseases (CKDs). As part of these clinical trial efforts, Walden has engaged a leading regulatory advisor and initiated targeted patient outreach services to position the program for successful execution.
WAL0921 is Walden’s first-in-class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR) and inhibits its pro-inflammatory action on podocytes that causes podocyte dysfunction, proteinuria, and kidney disease.
Walden has engaged Norman Stockbridge, M.D., Ph.D., Principal of S&S Consulting Partners LLC and former Director of the Division of Cardiology and Nephrology at the U.S. Food and Drug Administration (FDA), as a regulatory and clinical advisor. Dr. Stockbridge will provide strategic guidance on advancing Walden’s nephrology pipeline, including regulatory strategy and clinical development planning.
“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,” said Andrew Blair, M.D., Chief Medical Officer of Walden Biosciences. “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.”
In addition, Walden has entered into an agreement to utilize patient outreach and clinical study matching services from NephCure, a nonprofit organization that supports individuals living with rare, protein-spilling kidney diseases. Through this engagement, Walden aims to broaden awareness of its ongoing Phase 2 study among patients with proteinuria and rare kidney diseases as part of a multi-faceted approach to support patient recruitment.
“We are very pleased to be working with NephCure to advance our shared goal of transforming the treatment landscape for rare kidney disease patients,” said Blaine McKee, Ph.D., Chief Executive Officer of Walden Biosciences. “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,” added Dr. McKee.
About Dr. Stockbridge
Dr. Stockbridge is a distinguished physician-scientist and regulatory expert in cardiovascular and renal drug development. He served as the Director of the Division of Cardiovascular and Renal Products at the U.S. Food and Drug Administration (FDA), where he played a pivotal role in shaping regulatory strategies for therapies targeting heart and kidney diseases.
Dr. Stockbridge earned his M.D. and Ph.D. in Physiology from Duke University. He completed postdoctoral training at both Duke and New York Medical College, and later held academic and research positions, including a faculty role in the Department of Surgery at the University of Alberta, where he conducted basic cellular electrophysiology research. He began his regulatory career at the FDA in 1991, where he spent 34 years and held various leadership roles before becoming division director.
The Phase 2 Clinical Study
WAL0921-02 is an adaptive, prospective, multi-center, randomized, double-blind, placebo- controlled study to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of WAL0921 in subjects with glomerular kidney diseases and proteinuria, including diabetic nephropathy (DN) and rare glomerular kidney diseases, including focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), immunoglobulin A nephropathy (IgAN), and primary membranous nephropathy (PMN).
The study will enroll up to 96 subjects, randomized three-to-one (active:placebo). Initially, 44 subjects will be enrolled, with enrollment of the rare CKD Cohorts following the DN Cohorts. The study design is flexible and up to 52 additional subjects may be adaptively enrolled to further explore safety, efficacy, PK, and PD of WAL0921 by expanding or adding Cohorts (e.g., to improve statistical powering, explore alternative dosing schedules, or explore alternative dose levels). After showing stability on existing therapy for 12 weeks, subjects will be administered seven, sequential IV doses of WAL0921, or placebo, every 14 days over a 12-week treatment period and followed for an additional 24 weeks.
WAL0921-02 is supported by positive data from the Phase 1+ clinical study of WAL0921 (WAL0921-01). WAL0921-01 was a single center, placebo-controlled, single ascending dose study of WAL0921 in five cohorts that evaluated its safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects. Study data showed that WAL0921 was well- tolerated and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels.
About NephCure
NephCure’s mission is to empower people with rare, protein-spilling kidney diseases to take charge of their health while leading the revolution in research, new treatments, and care. Since 2000, NephCure has invested more than $40 million in kidney disease research and helped transform the treatment landscape through advocacy, education, and support. NephCure is a
U.S. tax-exempt 501(c)(3) public charity.
About Walden Biosciences
Walden Biosciences is a private, clinical development-stage company focused on developing novel, breakthrough, disease-modifying medicines to treat kidney diseases. Walden is applying novel, multi-disciplinary approaches that directly target the kidney to prevent damage, slow disease progression, and restore kidney function. Walden’s product candidates are well-differentiated from current therapies as they are not hemodynamic modulators, and they are non-immunosuppressive. Importantly, they can be broadly combined with the current standard of care and all agents in development.
Walden’s programs address novel targets for therapeutic intervention, directly targeting two cell types critical for kidney function: podocytes and proximal tubular cells. Dysfunction of these cells are critical hallmarks of the majority of kidney diseases. Walden’s Phase 2 clinical-stage program is a humanized monoclonal antibody, WAL0921, that inhibits suPAR, a cause of podocyte dysfunction and kidney disease, which is being evaluated in a Basket study. Walden’s second most advanced program is an IND-ready small molecule, WAL0623, that is designed to stabilize and restore the function of dynamin, an enzyme responsible for the maintenance of the cytoskeletal architecture and function of podocytes and proximal tubule cells. Both of Walden’s programs offer the promise to deliver disease-modifying, breakthrough therapies that are readily combinable with the standard of care to transform the treatment of kidney disease. For more information, please visit www.waldenbiosciences.com.
Investor and Media Contact:
Precision AQ
Anne Marie Fields
Managing Director
annemarie.fields@precisionaq.com
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