Delving into the Latest Updates on BI-764198 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

TRPC6

Mechanism

TRPC6 antagonists(transient receptor potential cation channel subfamily C member 6 antagonists)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication

Chronic Kidney DiseasesGlomerulosclerosis, Focal SegmentalGlomerular disease

Inactive Indication

COVID-19Respiratory DiseasesRespiratory Distress Syndrome, Adult

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization

Boehringer Ingelheim GmbHAlmac Pharma Services Ltd.Boehringer Ingelheim International GmbH

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.

Start Date03 May 2023

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTR20230035

/ Active, not recruitingPhase 2

一项在局灶性节段性肾小球硬化症患者中评估BI 764198每日一次口服给药12周的有效性、安全性、耐受性、药代动力学和药效学特征的多中心、随机、双盲、平行分组、安慰剂对照研究

[Translation] A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of BI 764198 orally administered once daily for 12 weeks in patients with focal segmental glomerulosclerosis

本研究的主要目的是探索3种剂量的BI 764198在降低蛋白尿方面的有效性

[Translation]

The primary objective of this study was to explore the effectiveness of 3 doses of BI 764198 in reducing proteinuria.

Start Date11 Apr 2023

Sponsor / Collaborator

Boehringer Ingelheim (China) Investment Co., Ltd.

[+2]

100 Clinical Results associated with BI-764198

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100 Translational Medicine associated with BI-764198

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100 Patents (Medical) associated with BI-764198

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2

Literatures (Medical) associated with BI-764198

01 Dec 2023·Kidney International Reports

TRPC6 Inhibitor BI 764198 in Focal Segmental Glomerulosclerosis: Phase 2 Study Design

Article

Author: Soleymanlou, Nima ; Trachtman, Howard ; Choi, Wansuk ; Kretzler, Matthias ; Desmond, Hailey E ; Manuel, Raymond C

01 Aug 2023·Thorax

TRPC6 inhibitor (BI 764198) to reduce risk and severity of ARDS due to COVID-19: a phase II randomised controlled trial

Article

Author: Kaste, Renee ; Gupta, Abhya ; Choi, Wansuk ; Welte, Tobias ; McAuley, Danny Francis ; Diaz, George A ; Estrada, Vicente ; Soleymanlou, Nima ; Lacamera, Peter ; Ware, Lorraine B

BackgroundDespite the availability of COVID-19 vaccinations, there remains a need to investigate treatments to reduce the risk or severity of potentially fatal complications of COVID-19, such as acute respiratory distress syndrome (ARDS). This study evaluated the efficacy and safety of the transient receptor potential channel C6 (TRPC6) inhibitor, BI 764198, in reducing the risk and/or severity of ARDS in patients hospitalised for COVID-19 and requiring non-invasive, supplemental oxygen support (oxygen by mask or nasal prongs, oxygen by non-invasive ventilation or high-flow nasal oxygen).MethodsMulticentre, double-blind, randomised phase II trial comparing once-daily oral BI 764198 (n=65) with placebo (n=64) for 28 days (+2-month follow-up). Primary endpoint: proportion of patients alive and free of mechanical ventilation at day 29. Secondary endpoints: proportion of patients alive and discharged without oxygen (day 29); occurrence of either in-hospital mortality, intensive care unit admission or mechanical ventilation (day 29); time to first response (clinical improvement/recovery); ventilator-free days (day 29); and mortality (days 15, 29, 60 and 90).ResultsNo difference was observed for the primary endpoint: BI 764198 (83.1%) versus placebo (87.5%) (estimated risk difference –5.39%; 95% CI –16.08 to 5.30; p=0.323). For secondary endpoints, a longer time to first response (rate ratio 0.67; 95% CI 0.46 to 0.99; p=0.045) and longer hospitalisation (+3.41 days; 95% CI 0.49 to 6.34; p=0.023) for BI 764198 versus placebo was observed; no other significant differences were observed. On-treatment adverse events were similar between trial arms and more fatal events were reported for BI 764198 (n=7) versus placebo (n=2). Treatment was stopped early based on an interim observation of a lack of efficacy and an imbalance of fatal events (Data Monitoring Committee recommendation).ConclusionsTRPC6 inhibition was not effective in reducing the risk and/or severity of ARDS in patients with COVID-19 requiring non-invasive, supplemental oxygen support.Trial registration numberNCT04604184.

100 Deals associated with BI-764198

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 1	US	Boehringer Ingelheim GmbH	03 Nov 2020
COVID-19	Phase 1	PR	Boehringer Ingelheim GmbH	03 Nov 2020
COVID-19	Phase 1	ES	Boehringer Ingelheim GmbH	03 Nov 2020
Respiratory Distress Syndrome, Adult	Phase 1	ES	Boehringer Ingelheim GmbH	03 Nov 2020
Respiratory Distress Syndrome, Adult	Phase 1	BR	Boehringer Ingelheim GmbH	03 Nov 2020
COVID-19	Preclinical	MX	Boehringer Ingelheim GmbH	03 Nov 2020
COVID-19	Preclinical	BR	Boehringer Ingelheim GmbH	03 Nov 2020
COVID-19	Preclinical	CL	Boehringer Ingelheim GmbH	03 Nov 2020
Respiratory Distress Syndrome, Adult	Preclinical	CL	Boehringer Ingelheim GmbH	03 Nov 2020
Respiratory Distress Syndrome, Adult	Preclinical	US	Boehringer Ingelheim GmbH	03 Nov 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04604184 (CTgov)	Phase 2	COVID-19 \| Respiratory Distress Syndrome, Adult	133	BI 764198 (BI 764198 Treatment Group)	unpnulcols(sjgeijpwif) = ufugkyvqgx cmxxfqmivf (xxqftbonme, qndpgsdrbm - cbqksdzlwi) View more	-	11 Apr 2022
				Placebo (Placebo)	unpnulcols(sjgeijpwif) = igbohnmygm cmxxfqmivf (xxqftbonme, ifqypalotf - dijopmovie) View more