Pharma Focus America

Walden Biosciences Commences Phase 1 Clinical Trial for WAL0921, an Investigational Therapy Targeting Chronic Kidney Diseases, as First Patient Receives Dose

Tuesday, June 06, 2023

Walden Biosciences, a privately held clinical development stage company focused on revolutionizing kidney disease treatment, has announced the initiation of its Phase 1 clinical trial for WAL0921. WAL0921 is a proprietary humanized monoclonal antibody developed by the company, designed to target soluble urokinase plasminogen activator receptor (suPAR). By inhibiting the pro-inflammatory action caused by suPAR, WAL0921 aims to address podocyte dysfunction and renal disease.

The dosing of the first subject in the Phase 1 trial marks a significant milestone for Walden Biosciences as it transitions into a clinical development company. The ultimate goal is to transform the treatment of kidney disease. Elevated suPAR levels contribute to kidney tissue inflammation, chronic injury, loss of podocytes, proteinuria, and overall compromise of kidney structure and function, leading to end-stage renal disease (ESRD). WAL0921 offers a novel and disease-modifying approach to directly target this causal agent.

The Phase 1 clinical trial is a single-center, placebo-controlled study involving single ascending dose escalations in five cohorts. The primary objectives are to evaluate the safety and tolerability of WAL0921, assess its pharmacokinetics (PK), and explore its pharmacodynamics (PD) in up to 40 healthy volunteers.

Dr. Blaine H. McKee, CEO of Walden Biosciences, expressed enthusiasm for the trial's progress and its potential impact on kidney disease treatment. The company expects to complete enrollment and report critical safety, PK, and PD data from multiple cohorts by the end of 2023.

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