Expects Topline Results from First Multiple Ascending Dose Cohort by Year-end 2024 and to Initiate Rare Kidney Disease Cohorts in Early 2025
CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company advancing disease modifying therapies to transform the treatment of kidney disease, today announced that it has completed initial dosing of all subjects in the first cohort of a Phase 2 basket study evaluating WAL0921 as a treatment for chronic kidney diseases. WAL0921 is Walden's first-in-class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR) and inhibits the pathological activity of suPAR that causes podocyte dysfunction and kidney disease.
The Phase 2 basket study will evaluate WAL0921 in individuals with glomerular kidney diseases and proteinuria. This study will enroll subjects with diabetic nephropathy (DN) and rare glomerular kidney diseases, including focal segmental glomerulosclerosis (FSGS), treatment resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN).
"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. 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,” stated Dr. Andrew Blair, Chief Medical Officer of Walden Biosciences.
"We look forward to generating topline data from cohort 1 by year-end 2024 and to advancing this Phase 2 basket study into rare kidney disease cohorts in early 2025,” added Dr. Blair.
"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. "Based on the data from preclinical studies and our compelling early clinical study, we believe WAL0921 has substantial therapeutic potential.”
The Phase 2 clinical study is supported by positive data from the recently completed Phase 1+ clinical study of WAL0921. The Phase 1+ clinical study was a single center, double-blind, placebo-controlled, single ascending dose study of WAL0921 in five cohorts that evaluated its safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects. Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels.
The Phase 2 Clinical Study
The Phase 2 clinical study 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), IgA nephropathy (IgAN) and membranous nephropathy (MN).
The study will enroll up to 96 subjects, randomized three-to-one (active:placebo). Initially, 44 subjects will be enrolled, with the rare kidney disease cohorts following the DN cohorts. The study is flexible and will be adapted to reflect the emerging data from the initial 44 subjects, 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 of subjects (e.g., to improve statistical powering, explore alternative dosing schedules, or explore alternative dose).
Subjects will be administered seven sequential IV doses of WAL0921 or placebo every 14 days over a 12-week treatment period and will be followed for an additional 24 weeks.
About Walden Biosciences
Walden Biosciences is a private, venture-backed Phase 2 clinical development-stage company focused on developing 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 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 clinical-stage program is a humanized monoclonal antibody that inhibits suPAR, a cause of podocyte dysfunction and kidney disease, which is being evaluated in a Phase 2 Basket study. Walden's second most advanced program is an IND-ready small molecule 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. All 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.
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