Walden Biosciences Completes Enrollment for Phase 2 Study of WAL0921 in Kidney Diseases

Walden Biosciences, Inc., a biotechnology firm based in Cambridge, Massachusetts, has announced the completion of initial dosing for all subjects in the first cohort of its Phase 2 basket study. The study is evaluating WAL0921, a novel humanized monoclonal antibody, for the treatment of chronic kidney diseases. WAL0921 targets the soluble urokinase plasminogen activator receptor (suPAR) to inhibit its detrimental effects on podocytes, thereby addressing kidney dysfunction and disease.

The Phase 2 basket study aims to assess WAL0921 in patients suffering from glomerular kidney diseases and proteinuria, including diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN). The study will provide insights into the safety and efficacy of WAL0921 across these different kidney conditions.

Dr. Andrew Blair, Chief Medical Officer of Walden Biosciences, emphasized the uniqueness of the study, which will determine the safety of multiple ascending doses (MAD) of WAL0921 in patients with kidney diseases. It also serves as a proof-of-concept for individual kidney diseases being evaluated. The initial phase involves administering two ascending doses to participants with diabetic nephropathy to establish safety and verify the pharmacodynamic effects observed in previous studies with healthy subjects.

Dr. Blair expressed optimism about the timeline for the study, anticipating topline data from the first cohort by the end of 2024. This will pave the way for the inclusion of rare kidney disease cohorts in early 2025. Blaine McKee, Ph.D., Chief Executive Officer of Walden, noted the swift progress made in initial dosing and highlighted the therapeutic potential of WAL0921, supported by both preclinical data and early clinical studies.

The Phase 2 clinical trial is underpinned by positive results from a recently completed Phase 1+ study, which was a single-center, double-blind, placebo-controlled, single ascending dose study. This earlier study evaluated the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in 40 healthy subjects. The results demonstrated that WAL0921 was safe, well-tolerated, and effective in rapidly reducing free suPAR levels in a dose-dependent manner.

The ongoing Phase 2 study is adaptive, prospective, multi-center, randomized, double-blind, and placebo-controlled. It will appraise the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in patients with glomerular kidney diseases and proteinuria. The study involves up to 96 subjects, with an initial enrollment of 44 participants, followed by the addition of rare kidney disease cohorts after the diabetic nephropathy cohorts. Depending on emerging data, up to 52 additional subjects may be enrolled to further investigate the safety, efficacy, and other parameters of WAL0921.

Participants in the study will receive seven sequential intravenous doses of WAL0921 or placebo every 14 days over a 12-week treatment period, followed by a 24-week observation period.

Walden Biosciences is focused on developing innovative, disease-modifying therapies to treat kidney diseases. The company employs multi-disciplinary approaches to directly target the kidneys, aiming to prevent damage, slow disease progression, and restore kidney function. Besides the clinical-stage WAL0921 program, Walden is also advancing an IND-ready small molecule designed to stabilize and restore the function of dynamin, an enzyme crucial for podocyte and proximal tubular cell function. Walden's programs hold the potential to deliver breakthrough therapies that can be combined with standard care to transform kidney disease treatment.