Jade Biosciences Announces First Cohort Dosed in Phase 1 Healthy Volunteer Clinical Trial of JADE101, a Novel and Potentially Best-in-Class Anti-APRIL Monoclonal Antibody Being Evaluated for the Treatment of IgA Nephropathy
Selective APRIL inhibition has shown disease-modifying potential in IgAN patient clinical trialsJADE101 has shown ultra-high binding affinity and a differentiated pharmacokinetic and pharmacodynamic profile preclinically, supporting the potential for patient-friendly subcutaneous dosing every eight weeks or longerInterim, biomarker-rich Phase 1 healthy volunteer data are expected in the first half of 2026, and are anticipated to define dose and dosing interval selection based on biomarker responses associated with optimal clinical activity in IgAN patientsSAN FRANCISCO and VANCOUVER, British Columbia, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. ("the Company" or "Jade"), (NASDAQ:JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced that it has dosed the first cohort of participants in a Phase 1 healthy volunteer trial of JADE101. JADE101 is the Company's investigational monoclonal antibody designed to selectively inhibit the activity of A PRoliferation-Inducing Ligand (APRIL) in patients with immunoglobulin A nephropathy (IgAN). The Company expects interim Phase 1 clinical data in the first half of 2026."We believe the anti-APRIL class is poised to be the foundational treatment for patients with IgAN, an autoimmune kidney disease that leads to end-stage kidney disease over the lifetime of most patients," said Andrew King, Ph.D., Chief Scientific Officer and Head of R&D at Jade Biosciences. "JADE101 has a differentiated preclinical profile, demonstrating femtomolar binding affinity to APRIL and deep and prolonged IgA reductions in non-human primates. These properties could lead to potentially capturing the full efficacy of the anti-APRIL mechanism and offering the most convenient dosing schedule in the class—an important consideration for a lifelong disease that typically affects otherwise healthy young adults. Our interim healthy volunteer data are expected to be highly informative, providing readouts on APRIL and IgA biomarkers, and are anticipated to define dose and dosing interval selection for later-stage IgAN patient studies."The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study evaluating single ascending subcutaneous doses of ...Full story available on Benzinga.com