Walden Biosciences announced two strategic initiatives to advance its WAL0921 development program, including the engagement of former FDA regulatory expert Norman Stockbridge, M.D., Ph.D., and a partnership with patient advocacy organization NephCure to support its ongoing Phase 2 clinical basket study in rare chronic kidney diseases.
Regulatory Expertise Addition
Walden has engaged Dr. Stockbridge, 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, 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."
Dr. Stockbridge brings 34 years of FDA experience, having begun his regulatory career in 1991 and holding various leadership roles before becoming division director. He earned his M.D. and Ph.D. in Physiology from Duke University and completed postdoctoral training at Duke and New York Medical College.
Patient Advocacy Partnership
The company has entered into an agreement with NephCure, a nonprofit organization supporting individuals with rare, protein-spilling kidney diseases, to utilize patient outreach and clinical study matching services. This partnership aims to broaden awareness of the 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 has invested more than $40 million in kidney disease research since 2000 and helped transform the treatment landscape through advocacy, education, and support.
WAL0921 Mechanism and Development
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.
Phase 2 Clinical Study Design
WAL0921-02 is an adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney diseases and proteinuria. The study targets diabetic nephropathy 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 diabetic nephropathy cohorts. The study design allows for up to 52 additional subjects to be adaptively enrolled to further explore safety, efficacy, pharmacokinetics, and pharmacodynamics by expanding or adding cohorts.
After demonstrating stability on existing therapy for 12 weeks, subjects will receive seven sequential intravenous doses of WAL0921 or placebo every 14 days over a 12-week treatment period and be followed for an additional 24 weeks.
Supporting Phase 1 Data
The Phase 2 study is supported by positive data from the Phase 1+ clinical study (WAL0921-01), a single-center, placebo-controlled, single ascending dose study that evaluated safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects across five cohorts. Study data showed that WAL0921 was well-tolerated and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels.
Timeline and Pipeline
"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," said Dr. McKee.
Walden's pipeline also includes WAL0623, an IND-ready small molecule designed to stabilize and restore the function of dynamin, an enzyme responsible for maintaining the cytoskeletal architecture and function of podocytes and proximal tubule cells. Both programs are designed as disease-modifying therapies that can be combined with current standard of care treatments.
