BI 764198 / Boehringer Ingelheim, Aurobac Therapeutics - LARVOL DELTA

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P3 | N=286 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2030 ➔ Dec 2029 | Trial primary completion date: Feb 2030 ➔ Nov 2029

Trial completion date • Trial primary completion date • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology

Population Pharmacokinetic and Exposure-Response Modeling Supports BI 764198 20 mg as the Therapeutic Dose for Phase 3, with No Dose Adjustment Required (KIDNEY WEEK 2025) - "Consistent with this, the median unbound BI 764198 C av,ss for the 20 mg dose (117 nmol/L; assuming 36.4% unbound fraction) corresponded to a >IC 90 of in vitro human TRPC6 inhibition, supporting the hypothesis that BI 764198 20 mg achieves a near-maximal pharmacodynamic effect. Conclusion The final popPK and E-R models support BI 764198 20 mg as the therapeutic dose for Phase III, with no dose adjustment required based on the covariates investigated."

Clinical • Late-breaking abstract • P3 data • PK/PD data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • TRPC6

TRPC6 Inhibition for the Treatment of FSGS: Phase 2 Randomized Controlled Trial of BI 764198 (KIDNEY WEEK 2025) - "Conclusion BI 764198 lowered proteinuria in FSGS and was well tolerated. This is the first evidence of efficacy with a podocyte-targeted therapy in FSGS."

Clinical • P2 data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease • TRPC6

Targeting Podocyte Calcium Influx with TRPC6 Inhibitor BI 764198: Implications for Glomerular Filtration Barrier Protection (KIDNEY WEEK 2025) - "These effects were reversed by the inhibitor, highlighting the potential role of BI 764198 in preventing TRPC6-mediated podocyte injury. Conclusion The findings provide in vitro validation of the therapeutic potential of the selective TRPC6 inhibitor BI 764198, shedding light on its protective mechanism of action."

Diabetes • CCND1 • PLAU • SPP1 • TRPC6

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P3 | N=286 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P3 trial • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology

A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment. (PubMed, Expert Opin Investig Drugs) - P1 | "Once-daily BI 764198 80 mg (10 days) did not alter midazolam PK. BI 764198 was well tolerated and could be taken with/without food; evaluation in FSGS is ongoing. The trials are registered at www.clinicaltrials.gov with codes NCT03854552; NCT04102462; NCT04656288; NCT04176536."

Journal • P1 data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Pain • Renal Disease

A randomized, phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men. (PubMed, Expert Opin Investig Drugs) - P1 | "BI 764,198 was well tolerated; exposure increased near dose proportionally to 80 mg, as previously observed in predominantly White volunteers. This study was registered on Clinical Trials.gov, identifier NCT04665700."

Journal • P1 data • PK/PD data • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Pain • Renal Disease • TRPC6

A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease • TRPC6

Targeting Podocyte Calcium Influx with TRPC6 Inhibitor BI 764198: Implications for Glomerular Filtration Barrier Protection (KIDNEY WEEK 2024) - "The findings provide in vitro validation of the therapeutic potential of the selective TRPC6 inhibitor BI 764198, shedding light on its protective mechanism of action."

Diabetes • TRPC6

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease • TRPC6

TRPC6 Inhibitor BI 764198 in Focal Segmental Glomerulosclerosis: Phase 2 Study Design. (PubMed, Kidney Int Rep) - No abstract available

Journal • P2 data • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease • TRPC6

A Study in Healthy Men to Test How BI 764198 is Processed in the Body (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Boehringer Ingelheim | Recruiting ➔ Completed | N=16 ➔ 24

Enrollment change • Trial completion

A Study in Healthy Men to Test How BI 764198 is Processed in the Body (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Men to Test How BI 764198 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jul 2023 ➔ Nov 2023 | Trial primary completion date: Jul 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date

A Study in Healthy Men to Test How BI 764198 is Processed in the Body (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=16 ➔ 8

Enrollment change • Enrollment closed

A Study in Healthy Men to Test How BI 764198 is Processed in the Body (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

TRPC6 inhibitor (BI 764198) to reduce risk and severity of ARDS due to COVID-19: a phase II randomised controlled trial. (PubMed, Thorax) - P2 | "TRPC6 inhibition was not effective in reducing the risk and/or severity of ARDS in patients with COVID-19 requiring non-invasive, supplemental oxygen support."

Journal • P2 data • Acute Respiratory Distress Syndrome • Critical care • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental Glomerulosclerosis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

Study Design of a Phase 2a trial of BI 764198, a Transient Receptor Potential Channel 6 (TRPC6) Inhibitor, in Focal Segmental Glomerulosclerosis (KIDNEY WEEK 2022) - P2 | "In the US, selected study centres will partake in the NEPTUNE (Nephrotic Syndrome Study Network) programme. As such, this study, as a NEPTUNE-Match trial, will help generate data towards a precision medicine approach for the care of patients with FSGS and help inform target patient populations for future trials of BI 764198 in FSGS and other proteinuric diseases."

P2a data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

Study Design of a Phase 2a trial of BI 764198, a Transient Receptor Potential Channel 6 (TRPC6) Inhibitor, in Focal Segmental Glomerulosclerosis (KIDNEY WEEK 2022) - P2 | "In the US, selected study centres will partake in the NEPTUNE (Nephrotic Syndrome Study Network) programme. As such, this study, as a NEPTUNE-Match trial, will help generate data towards a precision medicine approach for the care of patients with FSGS and help inform target patient populations for future trials of BI 764198 in FSGS and other proteinuric diseases."

P2a data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

Study Design of a Phase 2a trial of BI 764198, a Transient Receptor Potential Channel 6 (TRPC6) Inhibitor, in Focal Segmental Glomerulosclerosis (KIDNEY WEEK 2022) - P2 | "In the US, selected study centres will partake in the NEPTUNE (Nephrotic Syndrome Study Network) programme. As such, this study, as a NEPTUNE-Match trial, will help generate data towards a precision medicine approach for the care of patients with FSGS and help inform target patient populations for future trials of BI 764198 in FSGS and other proteinuric diseases."

P2a data • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental Glomerulosclerosis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2023 ➔ Feb 2024 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease