Walden Biosciences, Inc., a privately funded clinical development company specializing in innovative therapies for kidney diseases, has announced the results from its Phase 1+ clinical trial of WAL0921 in healthy individuals. WAL0921 represents Walden's novel humanized monoclonal antibody, designed to target circulating free soluble urokinase plasminogen activator receptor (suPAR) and its membrane-bound form, uPAR, thereby inhibiting their harmful effects implicated in kidney diseases.

Elevated suPAR levels are known to damage kidney tissues, leading to podocyte dysfunction and subsequent proteinuria. This structural and functional compromise in the kidneys can eventually progress to end-stage kidney disease necessitating dialysis.

Dr. Andrew Blair, Chief Medical Officer of Walden, remarked, "The results from our Phase 1+ trial are highly encouraging, showcasing WAL0921's capacity to effectively target and swiftly reduce free suPAR levels. This presents a truly innovative and disease-altering approach for various kidney diseases."

The Phase 1+ trial, conducted at a single center, involved a placebo-controlled, single ascending dose study of WAL0921 across five cohorts, encompassing 40 healthy participants. Data from the trial revealed the safety, tolerability, and proof-of-biology of WAL0921, demonstrating a rapid, dose-dependent reduction in free suPAR levels.

Dr. Blaine H. McKee, Chief Executive Officer of Walden, added, "These findings underscore the unique mechanism of WAL0921, targeting a pivotal pathway underlying kidney disease. They bolster our strategy to swiftly progress this promising candidate into a Phase 2 Basket study focusing on glomerular kidney diseases in the second quarter of 2024."

 

Source: globenewswire.com

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