Scientific Publications

Latest Publications

Conditional power and information fraction calculations at an interim analysis for random coefficient models
Pharmaceutical Statistics | November 2023

Identification of surrogate biomarkers reflecting tubular failed repair in CKD
American Society of Nephrology Kidney Week 2023 | November 2023

The ASSIST Trial: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
American Society of Nephrology Kidney Week 2023 | November 2023

Identification of non-invasive biomarkers reflecting cellular mechanisms of ETA activity and atrasentan response in CKD
American Society of Nephrology Kidney Week 2023 | November 2023

The BEYOND Trial: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart in Adults with IgA Nephropathy
American Society of Nephrology Kidney Week 2023 | November 2023

The AFFINITY Trial: An Open-label Phase 2 Study of Atrasentan in Patients with Proteinuric Glomerular Diseases
American Society of Nephrology Kidney Week 2023 | November 2023

BEYOND Study Design: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart in Adults with IgA Nephropathy
17th International Symposium on IgA Nephropathy | September 2023

ASSIST Study Design: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
17th International Symposium on IgA Nephropathy | September 2023

Updated Interim Results of a Phase 1/2 Study of Zigakibart (BION-1301) in Patients with IgA Nephropathy
17th International Symposium on IgA Nephropathy | September 2023

CHK-336, a First-in-Class Orally Administered LDH Inhibitor: Safety, PK and Target Engagement in a First-in-Human Phase 1 Healthy Volunteer Study
60th ERA Congress 2023 | June 2023

Accumulation of Maladaptive Tubular Epithelial Cells (TECs) is Ubiquitous in Chronic Kidney Diseases and Represents a Common Initiating Mechanism of Disease Progression
60th ERA Congress 2023 | June 2023

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart (BION-1301) in Adults with IgA Nephropathy
60th ERA Congress 2023 | June 2023

ASSIST Study Design: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
60th ERA Congress 2023 | June 2023

Updated Interim Results of a Phase 1/2 Study of Zigakibart (BION-1301) in Patients with IgA Nephropathy
60th ERA Congress 2023 | June 2023

Effects of Atrasentan on Markers of Liver Function in Patients with Type 2 Diabetes and Chronic Kidney Disease
Diabetes, Obesity and Metabolism | April 2023

Atrasentan in Patients with Proteinuric Glomerular Diseases – The AFFINITY Study
ISN World Congress of Nephrology 2023 | March 2023

Effects of Atrasentan on Markers of Liver Function in Patients with Type 2 Diabetes and Chronic Kidney Disease
ISN World Congress of Nephrology 2023 | March 2023

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy – The ALIGN Study
ISN World Congress of Nephrology 2023 | March 2023

Atrasentan for the Treatment of IgA Nephropathy: Interim Results of the AFFINITY Study
ISN World Congress of Nephrology 2023 | March 2023

Updated Interim Results of a Phase 1/2 Study of BION-1301 in Patients with IgA Nephropathy
ISN World Congress of Nephrology 2023 | March 2023

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy
ISN World Congress of Nephrology 2023 | March 2023

Accelerating the Development of BION-1301 for the Treatment of IgAN
Chronic Kidney Disease Drug Development Summit 2023 | March 2023

Unsupervised Characterization of the NURTuRE Cohort Reveals Gene Expression and Tissue Remodeling Dynamics along a Synthetic CKD Progression Axis
American Society of Nephrology Kidney Week 2022 | November 2022

A Multi-Omics Approach to IgA Nephropathy Characterization in the NURTuRE Cohort Enables Precision-Based Treatment Approaches
American Society of Nephrology Kidney Week 2022 | November 2022

Updated Interim Results of a Phase 1/2 Study of BION-1301 in Patients with IgA Nephropathy
American Society of Nephrology Kidney Week 2022 | November 2022

Preclinical Efficacy of CHK-336: A First in Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Primary Hyperoxalurias
American Society of Nephrology Kidney Week 2022 | November 2022

Atrasentan for the Treatment of IgA Nephropathy: Interim Results from the AFFINITY Study 
American Society of Nephrology Kidney Week 2022 | November 2022

Single Nuclei RNA-seq Reveals Cell-type Specific Responses to Disease and Enalapril in the gddY Mouse Model of IgAN
American Society of Nephrology Kidney Week 2022 | November 2022

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA NephropathyThe ALIGN Study
American Society of Nephrology Kidney Week 2022 | November 2022

Atrasentan in Patients with Proteinuric Glomerular Diseases – The AFFINITY Study
American Society of Nephrology Kidney Week 2022 | November 2022

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy 
American Society of Nephrology Kidney Week 2022 | November 2022

Defining Cellular Complexity in Human Autosomal Dominant Polycystic Kidney Disease by Multimodal Single Cell Analysis
Nature Communications | October 2022

Atrasentan for the Treatment of IgA Nephropathy: Interim Results from the AFFINITY Study
59th ERA Congress 2022 | May 2022

A Systems Nephrology Framework for the Molecular Classification of Chronic Kidney Disease
59th ERA Congress 2022 | May 2022

Updated Interim Results of a Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of BION-1301 in Patients with IgA Nephropathy
59th ERA Congress 2022 | May 2022

Selective Endothelin A Receptor Antagonist Atrasentan Attenuates Mesangial Cell Injury, Proteinuria and Intra-Renal Proliferative, Inflammatory and Fibrotic Transcriptional Networks in a Rat Model of Mesangioproliferative Glomerulonephritis
59th ERA Congress 2022 | May 2022

A Phase 1/2, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy
59th ERA Congress 2022 | May 2022

Neutralization of APRIL with BION-1301: A Targeted, Potentially Disease-Modifying Approach to IgA Nephropathy
4th Chronic Kidney Disease Drug Development Summit | March 2022

AFFINITY: A Phase 2 Basket Trial to Study the Safety and Efficacy of Atrasentan in Multiple Proteinuric Diseases
4th Chronic Kidney Disease Drug Development Summit | March 2022

Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
ISN World Congress of Nephrology 2022 | February 2022

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
ISN World Congress of Nephrology 2022 | February 2022

Pharmacodynamic and Clinical Responses to BION-1301 in Patients with IgA Nephropathy: Initial Results of a Phase 1/2 Trial (Encore)
ISN World Congress of Nephrology 2022 | February 2022

ADU-CL-19: a Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
ISN World Congress of Nephrology 2022 | February 2022

Atrasentan Publications

The ASSIST Trial: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
American Society of Nephrology Kidney Week 2023 | November 2023

Identification of non-invasive biomarkers reflecting cellular mechanisms of ETA activity and atrasentan response in CKD
American Society of Nephrology Kidney Week 2023 | November 2023

The AFFINITY Trial: An Open-label Phase 2 Study of Atrasentan in Patients with Proteinuric Glomerular Diseases
American Society of Nephrology Kidney Week 2023 | November 2023

ASSIST Study Design: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
17th International Symposium on IgA Nephropathy | September 2023

ASSIST Study Design: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Patients with IgA Nephropathy on SGLT2i
60th ERA Congress 2023 | June 2023

Effects of Atrasentan on Markers of Liver Function in Patients with Type 2 Diabetes and Chronic Kidney Disease
Diabetes, Obesity and Metabolism | April 2023

Atrasentan in Patients with Proteinuric Glomerular Diseases – The AFFINITY Study
ISN World Congress of Nephrology 2023 | March 2023

Effects of Atrasentan on Markers of Liver Function in Patients with Type 2 Diabetes and Chronic Kidney Disease
ISN World Congress of Nephrology 2023 | March 2023

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy – The ALIGN Study
ISN World Congress of Nephrology 2023 | March 2023

Atrasentan for the Treatment of IgA Nephropathy: Interim Results of the AFFINITY Study
ISN World Congress of Nephrology 2023 | March 2023

Single Nuclei RNA-seq Reveals Cell-type Specific Responses to Disease and Enalapril in the gddY Mouse Model of IgAN
American Society of Nephrology Kidney Week 2022 | November 2022

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA NephropathyThe ALIGN Study
American Society of Nephrology Kidney Week 2022 | November 2022

Atrasentan for the Treatment of IgA Nephropathy: Interim Results from the AFFINITY Study 
American Society of Nephrology Kidney Week 2022 | November 2022

Atrasentan in Patients with Proteinuric Glomerular Diseases – The AFFINITY Study
American Society of Nephrology Kidney Week 2022 | November 2022

Atrasentan for the Treatment of IgA Nephropathy: Interim Results from the AFFINITY Study
59th ERA Congress 2022 | May 2022

Selective Endothelin A Receptor Antagonist Atrasentan Attenuates Mesangial Cell Injury, Proteinuria and Intra-Renal Proliferative, Inflammatory and Fibrotic Transcriptional Networks in a Rat Model of Mesangioproliferative Glomerulonephritis
59th ERA Congress 2022 | May 2022

AFFINITY: A Phase 2 Basket Trial to Study the Safety and Efficacy of Atrasentan in Multiple Proteinuric Diseases
4th Chronic Kidney Disease Drug Development Summit | March 2022

Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
ISN World Congress of Nephrology 2022 | February 2022

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
ISN World Congress of Nephrology 2022 | February 2022

Atrasentan Exhibits a Consistent, Predictable Pharmacokinetic Profile Among Healthy Asian Adults 
American Society of Nephrology Kidney Week 2021 | November 2021

Precision Medicine Approach Identifies Patients with IgA nephropathy at Risk for Progression Using Endothelin Activation Signatures
American Society of Nephrology Kidney Week 2021 | November 2021

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
American Society of Nephrology Kidney Week 2021 | November 2021

Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
American Society of Nephrology Kidney Week 2021 | November 2021

A Central Role of Endothelin A (ETA) Receptor Activation in Mesangial Cell–Podocyte Crosstalk In IgA Nephropathy and Other Mesangio-Proliferative Glomerulopathies
13th International Podocyte Conference | July 2021

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress | June 2021

Selective ETA Antagonist Atrasentan, Rapidly Reduces Albuminuria and Downregulates Intra-renal Pro-Inflammatory and Pro-Fibrotic Transcriptional Networks in the g-ddY Mouse Model of Spontaneous IgA Nephropathy
ISN World Congress of Nephrology 2021 | April 2021

Human Renal Mesangial Cell Activation Induced by Endothelin-1 or IgA Nephropathy Patient Immune Derived Complexes is Blocked by Selective ETA Antagonist Atrasentan
ISN World Congress of Nephrology 2021 | April 2021

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy
(The ALIGN Study)

ISN World Congress of Nephrology 2021 | April 2021

Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
ISN World Congress of Nephrology 2021 | April 2021

A Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
American Society of Nephrology Kidney Week 2020 Reimagined | October 2020

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial
The Lancet | April 2019

SONAR propels endothelin A receptor antagonists to success
The Lancet | April 2019

A turning point for chronic kidney disease in diabetes
The Lancet | April 2019

Determining the optimal dose of atrasentan by evaluating the exposure-response relationships of albuminuria and bodyweight
Diabetes Obes Metab. | February 2018

The Endothelin Antagonist Atrasentan Lowers Residual Albuminuria in Patients with Type 2 Diabetic Nephropathy
Journal of the American Society of Nephrology | 2014

Endothelin and Endothelin Antagonists in Chronic Kidney Disease
Kidney Int. | November 2014

Zigakibart (BION-1301) Publications

The BEYOND Trial: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart in Adults with IgA Nephropathy
American Society of Nephrology Kidney Week 2023 | November 2023

BEYOND Study Design: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart in Adults with IgA Nephropathy
17th International Symposium on IgA Nephropathy | September 2023

Updated Interim Results of a Phase 1/2 Study of Zigakibart (BION-1301) in Patients with IgA Nephropathy
17th International Symposium on IgA Nephropathy | September 2023

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Zigakibart (BION-1301) in Adults with IgA Nephropathy
60th ERA Congress 2023 | June 2023

Updated Interim Results of a Phase 1/2 Study of Zigakibart (BION-1301) in Patients with IgA Nephropathy
60th ERA Congress 2023 | June 2023

Updated Interim Results of a Phase 1/2 Study of BION-1301 in Patients with IgA Nephropathy
ISN World Congress of Nephrology 2023 | March 2023

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy
ISN World Congress of Nephrology 2023 | March 2023

Accelerating the Development of BION-1301 for the Treatment of IgAN
Chronic Kidney Disease Drug Development Summit 2023 | March 2023

Updated Interim Results of a Phase 1/2 Study of BION-1301 in Patients with IgA Nephropathy
American Society of Nephrology Kidney Week 2022 | November 2022

A Phase 1/2 Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy 
American Society of Nephrology Kidney Week 2022 | November 2022

Updated Interim Results of a Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of BION-1301 in Patients with IgA Nephropathy
59th ERA Congress 2022 | May 2022

A Phase 1/2, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy
59th ERA Congress 2022 | May 2022

Neutralization of APRIL with BION-1301: A Targeted, Potentially Disease-Modifying Approach to IgA Nephropathy
4th Chronic Kidney Disease Drug Development Summit | March 2022

Pharmacodynamic and Clinical Responses to BION-1301 in Patients with IgA Nephropathy: Initial Results of a Phase 1/2 Trial (Encore)
ISN World Congress of Nephrology 2022 | February 2022

ADU-CL-19: a Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
ISN World Congress of Nephrology 2022 | February 2022

Pharmacodynamic and Clinical Responses to BION-1301 in Patients with IgA Nephropathy: Initial Results of a Ph1/2 Trial
American Society of Nephrology Kidney Week 2021 | November 2021

A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
American Society of Nephrology Kidney Week 2021 | November 2021

Interim Results of Phase 1 and 2 Trials to Investigate the Safety, Tolerability, Pharmacodynamics and Clinical Activity of BION-1301 in Patients with IgA Nephropathy
58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress | June 2021

ADU-CL-19 A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy
58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress | June 2021

A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Safety and Bioavailability Study of BION-1301 Administered by Intravenous (IV) and Subcutaneous (SC) Routes
ISN World Congress of Nephrology 2021 | April 2021

Results of a Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers (Encore)
American Society of Nephrology Kidney Week 2020 Reimagined | October 2020

Results of a Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers (Encore)
Asian Pacific Congress of Nephrology | October 2020

Results of a Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers
European Renal Association – European Dialysis and Transplant Association | June 2020

BION-1301, a Fully Blocking Antibody Targeting APRIL for the Treatment of IgA Nephropathy: Assessment of Safety, Toxicokinetics and Pharmacodynamics in Long-Term Nonclinical Studies
European Renal Association – European Dialysis and Transplant Association | June 2020

Nonclinical Safety and PK/PD of BION-1301, a Fully Blocking Antibody Targeting A PRoliferation Inducing Ligand (APRIL) for the Treatment of IgA Nephropathy
American Society of Nephrology Kidney Week | November 2019

BION-1301: a Novel fully Blocking APRIL Antibody for the Treatment of IgA Nephropathy
American Society of Nephrology | October 2018

CHK-336 Publications

CHK-336, a First-in-Class Orally Administered LDH Inhibitor: Safety, PK and Target Engagement in a First-in-Human Phase 1 Healthy Volunteer Study
60th ERA Congress 2023 | June 2023

Preclinical Efficacy of CHK-336: A First in Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Primary Hyperoxalurias
American Society of Nephrology Kidney Week 2022 | November 2022

Discovery & Characterization of CHK-336: A Liver-Targeted Small Molecule Inhibitor of Lactate Dehydrogenase A (LDHA) for the Treatment of Primary Hyperoxaluria (PH)
Rare & Genetic Kidney Disease Drug Development | December 2021

Discovery of CHK-336: A First-in-Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Hyperoxaluria
ISN World Congress of Nephrology 2021 | April 2021

Discovery of CHK-336: A First-in-Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Primary Hyperoxaluria
American Society of Nephrology Kidney Week 2020 Reimagined | October 2020

Research and Discovery Publications

Conditional power and information fraction calculations at an interim analysis for random coefficient models
Pharmaceutical Statistics | November 2023

Identification of surrogate biomarkers reflecting tubular failed repair in CKD
American Society of Nephrology Kidney Week 2023 | November 2023

Accumulation of Maladaptive Tubular Epithelial Cells (TECs) is Ubiquitous in Chronic Kidney Diseases and Represents a Common Initiating Mechanism of Disease Progression
60th ERA Congress 2023 | June 2023

Unsupervised Characterization of the NURTuRE Cohort Reveals Gene Expression and Tissue Remodeling Dynamics along a Synthetic CKD Progression Axis
American Society of Nephrology Kidney Week 2022 | November 2022

A Multi-Omics Approach to IgA Nephropathy Characterization in the NURTuRE Cohort Enables Precision-Based Treatment Approaches
American Society of Nephrology Kidney Week 2022 | November 2022

Single Nuclei RNA-seq Reveals Cell-type Specific Responses to Disease and Enalapril in the gddY Mouse Model of IgAN
American Society of Nephrology Kidney Week 2022 | November 2022

Defining Cellular Complexity in Human Autosomal Dominant Polycystic Kidney Disease by Multimodal Single Cell Analysis
Nature Communications | October 2022

A Systems Nephrology Framework for the Molecular Classification of Chronic Kidney Disease
59th ERA Congress 2022 | May 2022

Dual Glycolate Oxidase/Lactate Dehydrogenase A Inhibitors for Primary Hyperoxaluria
ACS Medicinal Chemistry Letters | May 2021

Single Cell Transcriptomic Analysis to Define Cellular Heterogeneity in Human ADPKD
American Society of Nephrology Kidney Week 2020 Reimagined | October 2020