Walden Biosciences is making strides in the development of disease-modifying therapies for kidney diseases, highlighted by the progress of its lead candidate, WAL0921, and the advancement of WAL0623. The company's efforts are focused on addressing unmet needs in both common and rare glomerular kidney diseases.
WAL0921 Phase 2 Basket Study
The Phase 2 clinical study (WAL0921-02) 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. WAL0921, a first-in-class antibody directed against soluble urokinase plasminogen activator receptor (suPAR), is being evaluated in a basket study including diabetic nephropathy (DN) and rare glomerular kidney diseases.
Blaine McKee, Ph.D., Chief Executive Officer of Walden Biosciences, stated, "Initial dosing from the first two Cohorts evaluating Walden’s anti-suPAR antibody in patients with diabetic nephropathy is complete and fully supports continued enrollment in the study’s Rare kidney disease patient population. We look forward to sharing data from the study, as Walden continues to advance our strategy of developing breakthrough, disease-modifying medicines that target the kidney."
The study has fully enrolled the second cohort, focusing on patients with diabetic nephropathy. The company plans to initiate the third cohort in early 2025, which will focus on rare glomerular kidney diseases, including focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN).
The study will enroll up to 96 subjects, randomized three-to-one (active:placebo). 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.
WAL0623: Dynamin Stabilizer
Walden Biosciences is also advancing WAL0623, a first-in-class small molecule dynamin stabilizer. The company has completed Investigational New Drug (IND)-enabling studies and plans to initiate a first-in-human Phase 1 clinical study. WAL0623 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.
2024 Accomplishments
In 2024, Walden Biosciences completed a first-in-human Phase 1+ clinical study of WAL0921 in healthy subjects. Data from the study showed that WAL0921 was well-tolerated and demonstrated proof-of-biology through a rapid reduction in suPAR.
Looking Ahead
Walden Biosciences anticipates delivering interim data on WAL0921-02 in rare glomerular kidney diseases. The company is also seeking to raise capital to support the advancement of its pipeline of disease-modifying therapies for the treatment of rare glomerular kidney diseases.
