Walden Biosciences Announces First Subject Dosed in First-in-Humans Phase 1 Clinical Trial of WAL0921, in Development for Treatment of Chronic Kidney Diseases

Trial to Evaluate Proprietary Human anti-suPAR Monoclonal Antibody for Safety, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

Expects to Complete Enrollment by Year End 2023

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) — Walden Biosciences, Inc. (Walden), a private, Series B, venture-backed clinical development stage company focused on transforming the treatment of kidney diseases, today announced that the first subject was dosed in the Company’s Phase 1 clinical trial of WAL0921 in healthy subjects. WAL0921 is the Company’s first in class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR), inhibiting the pro-inflammatory action that causes podocyte dysfunction and renal disease.

“Dosing the first subject in this first human study with WAL0921 is a meaningful milestone for Walden Biosciences that marks our transition to a clinical development company and brings us one step closer to our goal to transform the treatment of kidney disease,” stated Blaine H. McKee, Ph.D., Chief Executive Officer of Walden Biosciences. “Elevated levels of suPAR inflame kidney tissues leading to chronic injury, loss of podocytes, proteinuria, and compromise the whole kidney structure and function, leading ultimately to end stage renal disease (ESRD) in these patients. WAL0921 is designed to directly target this causal agent driving renal disease to provide a truly novel and disease-modifying approach for many chronic kidney diseases.”

The Phase 1 clinical trial is a single center, placebo-controlled single ascending dose escalation study in five chorts evaluating the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of WAL0921 in up to 40 healthy volunteers.

“The goal of this trial is to characterize the safety and tolerability of WAL0921, understand its single dose pharmacokinetic profile, and demonstrate its ability to safely reduce levels of free suPAR, which is a known cause of kidney disease. We are delighted to advance this important work and expect to complete enrollment of the Phase 1 trial and report critical safety, PK and PD data from multiple cohorts by year end 2023,” added Dr. McKee.

About Walden Biosciences
Walden Biosciences is focused on developing breakthrough, disease-modifying medicines to treat kidney diseases. Walden is applying novel, multi-disciplinary approaches that directly target the kidneys 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 renal diseases. Walden’s clinical-stage program is a humanized monoclonal antibody that inhibits suPAR, a pro-inflammatory mediator that causes podocyte dysfunction and renal disease. Walden’s second most advanced program is a small molecule that is designed to restore the function of dynamin, an enzyme responsible for the maintenance of the cytoskeletal architecture and function of podocytes and proximal tubule cells. In addition to the suPAR and dynamin programs, Walden also has a novel anti-fibrotic biologic in preclinical research. 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 renal disease. Walden was launched in late 2020 with a $51 million Series A round of financing led by ARCH Venture Partners with participation from other leading venture capital firms. For more information, please visit www.waldenbiosciences.com.

Investor Contact:
Stern Investor Relations
Anne Marie Fields
Managing Director
annemarie.fields@sternir.com

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