BION-1301

BION-1301 is a novel humanized anti-APRIL monoclonal antibody.

APRIL stands for A PRoliferation-Inducing Ligand. It is a TNF-family cytokine involved in B-cell signaling, regulating plasma cells and normal levels of immunoglobulin production. APRIL drives IgA production, the survival of IgA-producing plasma cells and increases secretion of Gd-IgA1 (Hit 1). APRIL gene variants increase risk for IgAN.

The hope is that BION-1301 will provide disease specific and disease modifying mechanism nephropathy by depleting Gd-IgA1, the pathogenic IgA variant, and reduce proteinuria

Enroll in this clinical study

Chinook Therapeutics

(206) 485-7051

clinicaltrials@chinooktx.com

How is BION-1301 being studied in IgA nephropathy?

Safety and tolerability of BION-1301 in health adults and volunteers with IgA nephropathy is a Phase 1/2 study of BION-1301.

The study will be conducted in three parts:

Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs).

Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs.

Part 3: Open-label, multiple dose (MD) in subjects with IgAN.

Parts 1 and 2 have been completed. The study is enrolling for Part 3.

The study will enroll up to 40 subjects with IgAN.

❗️Update

Interim analysis has shown that BION-1301 has been well tolerated in IgAN patients receiving a 450mg IV dose every two weeks for 12+ weeks with no SAEs or treatment related AE’s. Clinically meaningful reductions in proteinuria were seen at 12 weeks and were associated with the reduction in Gd-IgA1 levels.

Eligibility Criteria

Biopsy proven IgAN within past 10 years
Urine protein excretion of more than or equal to 0.5g/g in 24 hours
eGFR > 45ml/min
Stable on optimized dose of RASi for more than 3 months ( or intolerant to RASi) at the time of screening.