This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

开始日期2019-12-11

申办/合作机构

AbbVie, Inc.

EUCTR2018-000098-61-GB

/ Not yet recruiting临床2期

A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR

开始日期2018-06-22

申办/合作机构

Galapagos NV

NCT03589313

/ Completed临床1期

Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.

This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.

开始日期2018-02-12

申办/合作机构

Galapagos NV

100 项与 GLPG-3067 相关的临床结果

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100 项与 GLPG-3067 相关的转化医学

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100 项与 GLPG-3067 相关的专利（医药）

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项与 GLPG-3067 相关的新闻（医药）

2024-07-16

·药明康德

2.6亿美元助力开发潜在“first-in-class”心衰疗法；1.5亿美元推进新一代精准抗癌小分子开发……

▎药明康德内容团队编辑开发潜在“first-in-class”心衰疗法，新锐完成2.6亿美元B轮融资 Cardurion Pharmaceuticals公司今日宣布已完成2.6亿美元的B轮融资。获得资金将用于支持该公司两款主要候选药物的后期临床试验，这两款药物分别是治疗心力衰竭的潜在“first-in-class”磷酸二酯酶-9（PDE9）抑制剂和具有广泛治疗潜力的钙/钙调蛋白依赖性蛋白激酶II（CaMKII）抑制剂。此外，这些资金还将用于扩大Cardurion的候选药物管线在心血管适应症方面的应用、扩展研发管线等用途。该公司目前正在对其主打PDE9抑制剂CRD-750进行两项包含总计640名心力衰竭患者的2期临床试验。此外，公司还在进行其主打CaMKII抑制剂CRD-4730用于治疗儿茶酚胺多态性室性心动过速（CPVT）的2期临床试验。 1.5亿美元助力推进新一代精准抗癌小分子药物临床开发 Scorpion Therapeutics公司今日宣布已完成1.5亿美元的C轮融资。获得资金将用于推进其差异化小分子肿瘤学项目的研发，特别是扩展其别构、差异化、突变选择性PI3Kα抑制剂STX-478的临床试验。此外，该公司将继续推进其临床阶段的EGFR抑制剂系列，包括STX-721和STX-241，以及下一代精准癌症治疗的发现管线。 STX-478旨在改善携带PI3Kα突变患者的治疗效果，PI3Kα突变是癌症最常见的驱动因素之一。在临床前模型中，STX-478针对多种PI3Kα突变表现出强大的活性，同时在正常组织中避免了对野生型PI3Kα的抑制。非选择性PI3Kα抑制剂由于靶向毒性而对患者的益处有限。Scorpion的1/2期临床试验是一项多中心、全球性、开放标签研究，旨在评估STX-478治疗局部晚期或转移性HR+/HER2-乳腺癌和由PI3Kα突变驱动的其他实体肿瘤患者的安全性和疗效。该公司计划在未来的学术会议上披露初步的安全性、药代动力学和药效学数据以及初步疗效数据。针对免疫检查点抑制剂耐药性，1.5亿美元助力开发抗癌疗法 CatalYm公司今日宣布已完成1.5亿美元的D轮融资。获得资金将用于扩展公司主打疗法visugromab的2b期开发。Visugromab已经在与免疫检查点抑制剂联用的临床试验中展示了出色的抗肿瘤活性。 Visugromab是一种人源化单克隆抗体，旨在中和肿瘤产生的生长分化因子-15（GDF-15），GDF-15是肿瘤产生免疫抵抗的关键调节因子。CatalYm最近在2024年美国临床肿瘤学会（ASCO）年会上以口头报告形式发布了其正在进行1/2a期临床试验GDFATHER的积极数据。数据显示，visugromab与抗PD-1抗体nivolumab联用，在抗PD-1/PD-L1药物复发/难治性非小细胞肺癌（NSCLC）、尿路上皮癌（UC）或肝细胞癌（HCC）患者中实现了深度和持久的抗肿瘤活性，包括几例完全缓解。开发囊性纤维化创新组合疗法，新锐与艾伯维达成授权协议 Sionna Therapeutics公司今日宣布与艾伯维（AbbVie）达成授权协议，获得了多个临床阶段化合物的全球独家开发和商业化权利。根据协议条款，Sionna将承担galicaftor（ABBV-2222），一种靶向跨膜蛋白域1（TMD1）的囊性纤维化跨膜电导调节因子（CFTR）矫正剂，以及navocaftor（ABBV-3067），一种CFTR增强剂的所有开发责任，这两种药物均已完成2期研究。此外，Sionna还囊获处于1期临床开发阶段的TMD1靶向矫正剂ABBV-2851。艾伯维将收到一笔预付款、对Sionna的股权投资，并有资格获得后期开发和商业里程碑付款。在艾伯维进行的临床研究中，ABBV-2222和ABBV-3067安全和耐受性良好。在2期临床试验中，ABBV-2222与ABBV-3067联用展示了临床疗效，包括增加1秒用力呼气量百分比（ppFEV1）和降低汗液中氯离子（SwCl）水平，其效果与已批准的双调节剂组合相当。在由Sionna进行的包括囊性纤维化人体支气管上皮（CFHBE）在内的临床前实验中，Sionna靶向CFTR核苷酸结合域1（NBD1）的稳定剂与艾伯维的互补调节剂构成的双药组合显示出优于当前标准治疗的潜在疗效，并且一些组合有可能完全矫正ΔF508 CFTR突变体，达到野生型CFTR功能水平。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Cardurion Pharmaceuticals Announces $260 Million Series B Financing to Advance Its Pipeline of Innovative Medicines for Cardiovascular Diseases. Retrieved July 16, 2024, from https://cardurion.com/cardurion-pharmaceuticals-announces-260-million-series-b-financing-to-advance-its-pipeline-of-innovative-medicines-for-cardiovascular-diseases/ [2] Scorpion Therapeutics Announces $150 Million Series C Financing to Advance Leading Clinical-stage Precision Oncology Pipeline. Retrieved July 16, 2024, from https://www.scorpiontx.com/press-release/scorpion-therapeutics-announces-150-million-series-c-financing/ [3] CatalYm Announces New Financing of $150M to Support Broad Phase 2b Development Program for Visugromab. Retrieved July 16, 2024, from https://www.catalym.com/catalym-announces-new-financing-of-150m-to-support-broad-phase-2b-development-program-for-visugromab/ [4] SIONNA THERAPEUTICS EXPANDS PIPELINE WITH MULTIPLE CLINICAL STAGE CYSTIC FIBROSIS COMPOUNDS THROUGH A LICENSE AGREEMENT WITH ABBVIE. Retrieved July 16, 2024, from https://www.sionnatx.com/press-releases/sionna-therapeutics-expands-pipeline-with-multiple-clinical-stage-cystic-fibrosis-compounds-through-a-license-agreement-with-abbvie/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期ASCO会议临床结果临床1期

2024-07-16

·FierceBiotech

Sionna salvages AbbVie assets, teeing up dual combo assault on cystic fibrosis

The expansion of the pipeline gives Sionna a choice to make. Sionna Therapeutics has quickly found a use for some of its $182 million series C haul, inking a deal with AbbVie to add three clinical-phase candidates to its burgeoning pipeline of cystic fibrosis prospects. Boston-based Sionna has established itself as a potential threat to Vertex’s iron-grip on the cystic fibrosis market by advancing programs directly targeting correction of NBD1. The biotech has identified NBD1 correction as a way to fully restore CFTR function in patients with the most common mutation of the key cystic fibrosis protein. But it has also recognized combinations may be the route to the best results. Sionna fast tracked its combination ambitions Tuesday by picking up a trio of molecules from AbbVie. The acquired portfolio includes two midphase compounds, the CFTR corrector ABBV-2222 and the CFTR potentiator ABBV-3067. AbbVie studied ABBV-2222 and ABBV-3067, molecules respectively also called galicaftor and navocaftor, in combination with a C1 or C2 inhibitor in a midphase clinical trial. However, neither combination lived up to AbbVie’s expectations, prompting the company to stop the study and ax its cystic fibrosis program. AbbVie expanded in cystic fibrosis by paying Galapagos $45 million upfront in 2018. Sionna has also picked up the rights to a phase 1 corrector, ABBV-2851. The biotech said ABBV-2222 and ABBV-2851 are correctors directed at TMD1, one of the CTFR protein function domains. Sionna has its own TMD1-directed corrector, SION-676, in preclinical development, plus an ICL4-targeted candidate, SION-109, in phase 1. The expansion of the pipeline gives Sionna a choice to make. Pairing Sionna’s NBD1 stabilizers with any one of SION-109 and the three ex-AbbVie assets delivered better efficacy than the standard of care in a cystic fibrosis assay, the biotech said. Sionna will prioritize advancing one of the four compounds in a dual combination with its most advanced NBD1 stabilizer. AbbVie parted company with the assets in return for an upfront payment, an equity investment in Sionna and a chance to receive late-stage development and commercial milestones and royalties. Neither party has disclosed the size of the deal.

临床1期并购引进/卖出蛋白降解靶向嵌合体上市后研究

2024-07-16

·Firstwordpharma

Sionna breathes new life into AbbVie's abandoned CF compounds

A little over a year after AbbVie exited the cystic fibrosis (CF) space due to disappointing clinical results, Sionna Therapeutics is reviving the abandoned compounds, bagging exclusive worldwide rights to develop and commercialise multiple assets from the pharma.Financial specifics were not disclosed, but the deal includes an upfront payment to AbbVie along with potential late-stage development and commercial milestones and royalties. AbbVie has also made an equity investment in Sionna, which raised $182 million in an oversubscribed series C round earlier this year.The agreement encompasses ABBV-2222 (galicaftor) and ABBV-3067 (navocaftor), both of which have completed Phase II, and ABBV-2851, which is in Phase I development. ABBV-2222 and ABBV-2851 are both TMD1-directed correctors, while ABBV-3067 functions as a CFTR potentiator.AbbVie had discontinued its CF programme after a triple combination therapy that included the C2 corrector ABBV-576 added to a backbone of ABBV-2222 plus ABBV-3067 failed to meet efficacy criteria in a proof-of-concept study.Dual combinationsSionna, however, sees untapped potential in the compounds when combined with its proprietary NBD1 stabilisers, pointing to preclinical assays that have shown promising results. "Our strategy is to build a CF franchise anchored on our novel correctors that stabilise the NBD1 of the CFTR protein," said CEO Mike Cloonan.Sionna is looking to pair one of its NBD1 stabilisers with either an AbbVie compound or its own ICL4-directed corrector, SION-109, to create more effective dual combinations. The company reports that some pairings have shown promise in preclinical studies, with "potential for superior efficacy" over current treatments, while some combos have shown the ability "to fully correct ΔF508 CFTR and achieve wild type levels of CFTR function."Sionna has said it expects to complete a Phase I trial of SION-109 in the second half. Phase I studies of two NBD1 stabilisers, SION-451 and SION-719, are also due to start this year.Its most advanced NBD1 corrector is SION-638, which is poised to enter Phase II, while the company is also developing the TMD1-directed corrector SION-676.

临床1期引进/卖出临床2期蛋白降解靶向嵌合体

100 项与 GLPG-3067 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
囊性纤维化	临床2期	美国	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	比利时	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	加拿大	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	捷克	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	法国	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	匈牙利	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	荷兰	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	新西兰	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	波兰	AbbVie, Inc.	2019-12-11
囊性纤维化	临床2期	塞尔维亚	AbbVie, Inc.	2019-12-11

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03969888 (CTgov)	临床2期	囊性纤维化	78	Placebo ABBV-2222+ABBV-3067 (ABBV-3067 50 mg + Placebo for ABBV-2222)	選製餘糧齋憲鹽顧鏇選(觸鏇構衊觸構鏇鑰範選) = 鏇鬱餘淵廠鹽壓糧構積淵襯願夢鑰構壓襯觸餘 (觸憲餘憲鹽鬱願襯繭獵, 構艱壓壓範鏇糧餘餘選 ~ 廠願繭廠齋選壓醖廠觸) 更多	-	2023-06-28
				Placebo ABBV-2222+ABBV-3067 (ABBV-3067 150 mg + Placebo for ABBV-2222)	選製餘糧齋憲鹽顧鏇選(觸鏇構衊觸構鏇鑰範選) = 齋繭願獵廠遞網網鬱膚淵襯願夢鑰構壓襯觸餘 (觸憲餘憲鹽鬱願襯繭獵, 醖夢鬱顧窪憲廠鹽蓋鹹 ~ 構獵觸壓鬱簾網鹹網鏇) 更多