A Retrospective Chart Review: Current Status of Patients with Borderline Personality Disorder (BPD) and Medical Care in Japan - Chart Review for BPD in Japan

开始日期2024-04-12

申办/合作机构

Nippon Boehringer Ingelheim Co., Ltd.

JPRN-UMIN000052793 / SuspendedN/A

An exploratory study to identify the factors related to recurrence of Generalized Pustular Psoriasis (GPP) flare in adult patients with GPP in Japan - An exploratory study to identify the factors related to recurrence of GPP flare

开始日期2023-11-22

申办/合作机构

Nippon Boehringer Ingelheim Co., Ltd.

JPRN-UMIN000053706 / CompletedN/A

Real World Characterization of Patients with Advanced or Metastatic Liposarcoma in Japan - Real World Characterization of Patients with Advanced or Metastatic Liposarcoma in Japan

开始日期2023-08-04

申办/合作机构

Nippon Boehringer Ingelheim Co., Ltd.

100 项与 Nippon Boehringer Ingelheim Co., Ltd. 相关的临床结果

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307

项与 Nippon Boehringer Ingelheim Co., Ltd. 相关的文献（医药）

2024-09-19·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A randomized phase I study of the safety and pharmacokinetics of BI 1291583 in healthy Japanese male subjects.

Article

作者: Tadayasu, Yusuke ; Sauter, Wiebke ; Furuichi, Takumi ; Eleftheraki, Anastasia ; Sarubbi, Donald ; Nakamura, Shuhei ; Hanada, Ryuzo

AIMS:

Bronchiectasis patients face an unmet need for treatment options that reduce inflammation. Cathepsin C inhibition is expected to achieve this by reducing the activation of neutrophil-derived serine proteases. Here, we present safety and pharmacokinetic (PK) data from a Phase I trial evaluating the novel cathepsin C inhibitor BI 1291583 in healthy Japanese male subjects.

METHODS:

This randomized, double-blind, placebo-controlled, parallel-group study investigated BI 1291583 in healthy Japanese male subjects (jRCT2071210111) and consisted of a single-rising-dose (SRD) part and a multiple-dose (MD) part. The primary endpoint was the percentage of subjects with drug-related treatment-emergent adverse events (AEs). Secondary PK endpoints (SRD: AUC_0-∞ and C_max; MD: AUC_τ,1 and C_max,1 after first dose and AUC_τ,ss and C_max,ss after last dose), as well as further safety and PK endpoints, were also assessed.

RESULTS:

Overall, 36 subjects (n = 24 for SRD part; n = 12 for MD part) entered this Phase I trial. BI 1291583 was safe and well tolerated across the doses tested. All AEs were of mild intensity, with no drug-related treatment-emergent AEs, deaths, serious AEs or AEs of special interest reported in either part of the trial. Following both SRD and MD administration, BI 1291583 was readily absorbed, and PK was supraproportional over the doses assessed.

CONCLUSION:

The results show that BI 1291583 has an appropriate benefit-risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied. Japanese patients with bronchiectasis can be safely integrated into future global clinical trials of BI 1291583, with no dose adjustment required.

2024-09-01·iScience

Efficient proximal tubule-on-chip model from hiPSC-derived kidney organoids for functional analysis of renal transporters

Article

作者: Fujimoto, Kazuya ; Araoka, Toshikazu ; Ishiguro, Naoki ; Sadeghian, Ramin Banan ; Yokokawa, Ryuji ; Negoro, Ryosuke ; Banan Sadeghian, Ramin ; Takasato, Minoru ; Ma, Cheng

Renal transporters play critical roles in predicting potential drug-drug interactions. However, current in vitro models often fail to adequately express these transporters, particularly solute carrier proteins, including organic anion transporters (OAT1/3), and organic cation transporter 2 (OCT2). Here, we developed a hiPSC-derived kidney organoids-based proximal tubule-on-chip (OPTC) model that emulates in vivo renal physiology to assess transporter function. Compared to chips based on immortalized cells, OPTC derived from the two most commonly used differentiation protocols exhibited significant improvement in expression level and polarity of OAT1/3 and OCT2. Hence, the OPTC demonstrates enhanced functionality in efflux and uptake assessments, and nephrotoxicity. Furthermore, these functionalities are diminished upon adding inhibitors during substrate-inhibitor interactions, which were closer to in vivo observations. Overall, these results support that OPTC can reliably assess the role of renal transporters in drug transport and nephrotoxicity, paving the way for personalized models to assess renal transport and disease modeling.

2024-09-01·JOURNAL OF PSYCHOPHARMACOLOGY

Safety, tolerability and pharmacokinetics of the phosphodiesterase 2 inhibitor BI 474121: An overview of phase I randomized trials in healthy volunteers

Article

作者: Scholz, Andreas ; Schaible, Jennifer ; Yamamura, Norio ; Goeldner, Rainer-Georg

Background::

Cognitive impairment associated with schizophrenia predicts poor functional outcomes, but currently no efficacious pharmacotherapies are available.

Aims::

Four phase I trials examined the safety, tolerability and pharmacokinetics of the phosphodiesterase 2 inhibitor BI 474121, along with potential drug–drug interactions.

Methods::

Trial 1 evaluated single rising doses (SRDs) of BI 474121 versus placebo in healthy males. The influence of drug formulation and food on drug bioavailability was also examined. Trial 2 evaluated SRD of BI 474121 versus placebo in healthy Japanese males. Trial 3 evaluated multiple rising doses of BI 474121 in healthy young (with/without midazolam) and elderly (without midazolam) participants versus placebo. Trial 4 investigated interactions between itraconazole and single-dose BI 474121 in healthy males.

Results/Outcomes::

No deaths, serious adverse events (AEs), severe AEs or protocol-specified AEs of special interest were observed. BI 474121 absorbed rapidly during fasting, achieved maximum concentration of analyte in plasma and dose proportionality via tablet formulation, and decreased in a multiphasic manner. BI 474121 steady state occurred within 11 days of multiple oral administration. Multiple doses increased BI 474121 plasma concentrations, but did not alter the time course of plasma concentrations. Urinary excretion of unchanged BI 474121 was negligible. No clinically relevant inhibition or induction of CYP3A4 by BI 474121 was observed. Itraconazole co-administration produced higher exposures of BI 474121 versus BI 474121 alone.

Conclusions/Interpretation::

BI 474121 demonstrated favourable safety and pharmacokinetic profiles in healthy Caucasian and Japanese individuals, supporting further clinical development.

项与 Nippon Boehringer Ingelheim Co., Ltd. 相关的新闻（医药）

2022-10-18

·药渡Daily

Spesolimab：首个靶向IL-36通路治疗泛发性脓疱型银屑病！

2022年10月14日，勃林格殷格翰宣布，公司收到欧洲药品管理局人用药品管理委员会 (CHMP) 一项积极建议，其建议给予勃林格殷格翰新药Spesolimab作为治疗成人泛发性脓疱型银屑病 (GPP) 发作的同类首创治疗药物有条件的上市许可。来源：勃林格殷格翰官网此次来自CHMP的积极建议是基于EFFISAYIL® 1研究（NCT03782792）结果，该研究是一项为期12周的、多中心、双盲、随机、安慰剂对照的II期临床研究，共招募53名中至重度 GPP发作患者，患者按 2:1的比例随机接受Spesolimab 900 mg单剂静脉注射或安慰剂治疗。旨在评估Spesolimab单剂量用于治疗GPP患者的有效性、安全性和耐受性。该研究是针对泛发性脓疱型银屑病（GPP）发作患者的最大的临床研究。来源：药渡数据库结果显示：一周后，接受Spesolimab治疗的患者中有54%的患者无可见的脓疱，而安慰剂组为 6%。来源：DOI: 10.1056/NEJMoa211156312周后，5名患者中有4名以上 (84.4%) 无可见脓疱，皮肤清除/几乎清除 (81.3%)。一周后，66%接受Spesolimab治疗的患者和56%接受安慰剂治疗的患者报告了不良事件。Spesolimab治疗组和安慰剂治疗组中分别有17%和6%的患者报告了感染（在治疗第一周）。接受Spesolimab治疗的患者中有6%报告了严重不良事件（在治疗第一周）。来源：DOI: 10.1056/NEJMoa2111563SpesolimabSpesolimab是一款新型人源化选择性抗体，可阻断白介素-36受体（IL-36R）的激活。IL-36通路是免疫系统内的一种信号通路，已被证明与GPP等多种自身免疫性疾病的发病机制病因有关。GPP发病机制来源：DOI: 10.2340/00015555-2808 Spesolimab是勃林格殷格翰原研的首个专门靶向IL-36通路治疗GPP发作的在研疗法，已在一项随机、安慰剂对照研究中获得了具有统计学意义的结果。根据药渡数据调研，目前Spesolimab针对其他与免疫介导相关的疾病也在临床研究中，如：治疗化脓性汗腺炎、嗜中性粒细胞性皮肤病以及克罗恩病。Spesolimab临床研究进展来源：药渡数据库里程碑事件2022年9月26日，Spesolimab获PMDA批准上市，由Nippon Boehringer Ingelheim Co Ltd销售，用于治疗成人泛发性脓疱型银屑病 (GPP) 发作。2022年9月1日，Spesolimab获FDA批准上市，由Boehringer Ingelheim Pharmaceuticals Inc销售，商品名是Spevigo®，为一种静脉注射剂，规格是900MG，用于治疗成人泛发性脓疱型银屑病 (GPP) 发作。Spesolimab获批时光轴来源：药渡数据库根据药渡数据调研，目前，Spesolimab正在全球多个国家接受监管机构的评审。迄今为止，Spesolimab用于治疗GPP发作已在美国、中国大陆和台湾地区获得突破性治疗药物认定，在美国和中国获得优先审评资格，在美国、韩国、瑞士和澳大利亚获得孤儿药认定，在中国台湾地区被认定为罕见病并获得快速评审通道。泛发性脓疱型银屑病泛发性脓疱型银屑病（GPP）是一种罕见的、异质性的、可危及生命的嗜中性粒细胞性皮肤病，临床上与斑块状银屑病不同。GPP是由中性粒细胞（一种白细胞）在皮肤中积聚引起的，会在全身广泛爆发疼痛性的无菌性脓疱。GPP在不同区域的患病率各不相同，女性患者多于男性患者。GPP患者的临床病程各不相同，有些患者的疾病复发并伴有反复发作，而另一些患者的疾病持续存在且间歇性发作。虽然GPP发作的严重程度各不相同，但若不及时治疗，会出现败血症和多系统器官衰竭等并发症，可能会危及生命。这种慢性全身性疾病会对患者的生活质量产生重大影响，并增加医疗负担。对于能够快速解决GPP发作症状并能预防复发，且具有可接受的安全性的疗法存在着高度未满足的需求。2021年10月，欧洲药品管理局已验证Spesolimab用于治疗GPP的上市申请，今天的积极意见将为欧洲的GPP患者带来希望。参考来源勃林格殷格翰官网药渡数据库扫一扫，申请药渡数据免费试用

孤儿药优先审批突破性疗法快速通道抗体

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