Walden Biosciences, Inc. has announced the completion of initial dosing for all subjects in the first cohort of its Phase 2 basket study of WAL0921, a novel treatment for chronic kidney diseases. This marks a significant step in the development of a potentially disease-modifying therapy for patients with glomerular kidney diseases and proteinuria.
The Phase 2 study is an adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of WAL0921. The trial will enroll up to 96 subjects with glomerular kidney diseases, including diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN).
Study Design and Objectives
The study begins with 44 subjects, and may adaptively enroll up to 52 additional subjects. Subjects will be randomized three-to-one (active:placebo) and administered seven sequential IV doses of WAL0921 or placebo every 14 days over a 12-week treatment period, followed by a 24-week follow-up. The primary objectives are to assess the safety and tolerability of WAL0921 in this patient population and to gather proof-of-concept data for each individual kidney disease being assessed.
"This study is unique in that it will establish safety in a multiple ascending dose (MAD) study of WAL0921 in a diseased population and will also serve as proof-of-concept for each individual kidney disease being assessed," said Dr. Andrew Blair, Chief Medical Officer of Walden Biosciences. "The study initially evaluates two ascending doses in subjects with diabetic nephropathy to establish safety and confirm the pharmacodynamic effect of lowering suPAR that we saw in healthy subjects in our Phase 1+ clinical study."
WAL0921: Targeting suPAR in Kidney Disease
WAL0921 is a first-in-class, proprietary, humanized monoclonal antibody designed to bind to soluble urokinase plasminogen activator receptor (suPAR) and inhibit its pathological activity. SuPAR is implicated in causing podocyte dysfunction, a key factor in the development and progression of kidney disease. By targeting suPAR, WAL0921 aims to prevent kidney damage, slow disease progression, and potentially restore kidney function.
Prior Clinical Data
The Phase 2 clinical study is supported by positive data from a recently completed Phase 1+ clinical study of WAL0921. This earlier study was a single-center, double-blind, placebo-controlled, single ascending dose study in 40 healthy subjects. The results demonstrated that WAL0921 was safe, well-tolerated, and exhibited a rapid, dose-dependent reduction in free suPAR levels, providing proof-of-biology.
Anticipated Milestones
Walden Biosciences anticipates generating topline data from the first cohort of the Phase 2 study by the end of 2024. The company plans to initiate the rare kidney disease cohorts in early 2025. "We are pleased to have swiftly completed initial dosing of the first cohort in the MAD portion of our Phase 2 study as it moves us one step closer to bringing this potentially disease-modifying treatment to chronic kidney disease patients," stated Blaine McKee, Ph.D., Chief Executive Officer of Walden.
