A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in this patient population.

开始日期2024-11-15

申办/合作机构

Endeavor BioMedicines, Inc

NCT05817240

/ Completed临床1期

A Phase 1, Single-Center, Fixed Sequence, Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.

开始日期2023-05-03

申办/合作机构

Endeavor BioMedicines, Inc

NCT05199584

/ Active, not recruiting临床2期

A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF) mutations in the Patched-1 (PTCH1) gene. Stage 1 of this study will enroll approximately 44 patients randomized between two dose levels. As appropriate, Stage 2 of the study will expand enrollment based on the results of Stage 1.

开始日期2022-05-24

申办/合作机构

Endeavor BioMedicines, Inc

100 项与 Taladegib 相关的临床结果

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100 项与 Taladegib 相关的转化医学

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100 项与 Taladegib 相关的专利（医药）

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项与 Taladegib 相关的文献（医药）

2024-10-01·ARCHIV DER PHARMAZIE

A novel indole derivative, 2‐{3‐[1‐(benzylsulfonyl)piperidin‐4‐yl]‐2‐methyl‐1H‐indol‐1‐yl}‐1‐(pyrrolidin‐1‐yl)ethenone, suppresses hedgehog signaling and drug‐resistant tumor growth

Article

作者: Kim, Minkyoung ; Ko, Hyuk Wan ; Jeon, Jiyeon ; Lee, Yoon Ji ; Lee, Kyeong ; Lee, Hankyu ; Jung, Joo Hyun ; Nada, Hossam ; Lee, Hwayoung ; Bhattarai, Deepak

Abstract:

The Hedgehog (Hh) signaling pathway plays important roles in various physiological functions. Several malignancies, such as basal cell carcinoma (BCC) and medulloblastoma (MB), have been linked to the aberrant activation of Hh signaling. Although therapeutic drugs have been developed to inhibit Hh pathway‐dependent cancer growth, drug resistance remains a major obstacle in cancer treatment. Here, we show that the newly identified, 2‐{3‐[1‐(benzylsulfonyl)‐1,2,3,6‐tetrahydropyridin‐4‐yl]‐2‐methyl‐1H‐indol‐1‐yl}‐1‐(pyrrolidin‐1‐yl)ethenone analog (LKD1214) exhibits comparable potency to vismodegib in suppressing the Hh pathway activation. LKD1214 represses Smoothened (SMO) activity by blocking its ciliary translocation. Interestingly, we also identified that it has a distinctive binding interface with SMO compared with other SMO‐regulating chemicals. Notably, it maintains an inhibitory activity against the SmoD477H mutant, as observed in a patient with vismodegib‐resistant BCC. Furthermore, LKD1214 inhibits tumor growth in the mouse model of MB. Collectively, these findings suggest that LKD1214 has the therapeutic potential to overcome drug‐resistance in Hh‐dependent cancers.

2023-12-01·Cold Spring Harbor molecular case studies

Prostate cancer patient stratification by molecular signatures in the Veterans Precision Oncology Data Commons

Article

作者: Fillmore, Nathanael R ; La, Jennifer ; Hernandez, Kyle M ; Sung, Feng-Chi ; Metoki-Shlubsky, Noah ; Liu, Qiong ; Bihn, John R ; Grossman, Robert L ; Prokhorenkov, Andrew ; Brophy, Mary T ; Venkat, Aarti ; Paller, Channing J ; Elbers, Danne C ; Do, Nhan V

Veterans are at an increased risk for prostate cancer, a disease with extraordinary clinical and molecular heterogeneity, compared with the general population. However, little is known about the underlying molecular heterogeneity within the veteran population and its impact on patient management and treatment. Using clinical and targeted tumor sequencing data from the National Veterans Affairs health system, we conducted a retrospective cohort study on 45 patients with advanced prostate cancer in the Veterans Precision Oncology Data Commons (VPODC), most of whom were metastatic castration-resistant. We characterized the mutational burden in this cohort and conducted unsupervised clustering analysis to stratify patients by molecular alterations. Veterans with prostate cancer exhibited a mutational landscape broadly similar to prior studies, includingKMT2AandNOTCH1mutations associated with neuroendocrine prostate cancer phenotype, previously reported to be enriched in veterans. We also identified several potential novel mutations inPTEN,MSH6,VHL,SMO, andABL1. Hierarchical clustering analysis revealed two subgroups containing therapeutically targetable molecular features with novel mutational signatures distinct from those reported in the Catalogue of Somatic Mutations in Cancer database. The clustering approach presented in this study can potentially be used to clinically stratify patients based on their distinct mutational profiles and identify actionable somatic mutations for precision oncology.

2022-11-24·Journal of biomolecular structure & dynamics

Deep-learning based repurposing of FDA-approved drugs againstCandida albicansdihydrofolate reductase and molecular dynamics study

Article

作者: Joshi, Tanuja ; Chandra, Subhash ; Pundir, Hemlata

Candida albicans causes the fatal fungal bloodstream infection in humans called Candidiasis. Most of the Candida species are resistant to the antifungals used to treat them. Drug-resistant C. albicans poses very serious public health issues. To overcome this, the development of effective drugs with novel mechanism(s) of action is requisite. Drug repurposing is considered a viable alternative approach to overcome the above issue. In the present study, we have attempted to identify drugs that could target the essential enzyme, dihydrofolate reductase of C. albicans (CaDHFR) to find out potent and selective antifungal antifolates. FDA-approved-drug-library from the Selleck database containing 1930 drugs was screened against CaDHFR using deep-learning, molecular docking, X-score and similarity search methods. The screened compounds showing better binding with CaDHFR were subjected to molecular dynamics simulation (MDS). The results of post-MDS analysis like RMSD, RMSF, RG, SASA, the number of hydrogen bonds and PCA suggest that Paritaprevir, Lumacaftor and Rifampin can make good interaction with CaDHFR. Furthermore, analysis of binding free energy corroborated the stability of interactions as they had binding energy of -114.91 kJ mol^-1, -79.22 kJ mol^-1 and -78.52 kJ mol^-1 for Paritaprevir, Lumacaftor and Rifampin respectively as compared to the reference (-63.10 kJ mol^-1). From the results, we conclude that these drugs have great potential to inhibit CaDHFR and would add to the drug discovery against candidiasis, and hence these drugs for repurposing should be explored further.

项与 Taladegib 相关的新闻（医药）

2025-05-21

·药明康德

同行致远，Endeavor公布小分子2期积极结果；超20亿美元！罗氏再达抗癌分子胶合作……

肺纤维化小分子抑制剂2期试验积极结果公布日前，Endeavor BioMedicines公布其在研主打疗法ENV-101（taladegib）完成的2a期临床试验的事后分析结果。Endeavor BioMedicines的首席执行官John Hood博士过去接受访问时曾提到，过去20多年来，药明康德始终是值得信赖的合作伙伴。Hood博士强调：“时间经常是最宝贵的资源，我确信药明康德能够按时、高质量地提供我们需要的服务。”此次公布的数据显示，与安慰剂相比，接受ENV-101治疗12周的特发性肺纤维化（IPF）患者表现出肺血管容积显著减少、肺容量显著增加，并且肺纤维化程度有改善趋势等积极疗效。具体关键分析结果如下：肺容量显著增加：ENV-101治疗组患者肺容量显著提升（安慰剂组：−113.07 mL；ENV-101组：142.28 mL；p=0.014）。肺纤维化趋势改善：ENV-101治疗组患者肺纤维化程度改善趋势明显（安慰剂组：1.32 pp；ENV-101组：−1.32 pp；p=0.063）。肺血管容积显著减少：ENV-101治疗组患者的标准化肺血管容积显著降低（安慰剂组：0.07 pp；ENV-101组：−0.25 pp；p=0.0007）。▲Endeavor Biomedicines的首席执行官John Hood博士ENV-101是一款Hedgehog信号通路小分子抑制剂，通过结合并抑制Hedgehog通路中的关键受体，阻止导致纤维化的肌成纤维细胞异常积聚，从而有望逆转肺纤维化中持续性的创伤修复过程，改善肺部容量与功能。罗氏再达超20亿美元抗癌分子胶研发合作Orionis Biosciences今日宣布，已与罗氏（Roche）旗下基因泰克（Genentech）达成第二项多年期合作协议，双方将合作开发用于肿瘤领域的新型小分子单价分子胶药物，这些药物靶向具高挑战性的靶点。此前，Orionis曾于2023年9月与基因泰克开展首项合作，致力于发现适用于肿瘤和神经退行性疾病等重大疾病领域的创新小分子药物。Orionis的Allo-Glue小分子平台整合了多项专有技术，推动用于高挑战性疾病靶点的分子胶药物的发现与设计。该平台融合了先进的化学生物学工具、工程化细胞检测系统、定制构建的高通量自动化设备，以及专门的人工智能（AI）基础架构，能够在细胞内生成并分析数亿次蛋白相互作用事件。其AI驱动的化学引擎整合了预测建模、生成式设计以及化合物筛选系统，涵盖广泛化学空间，从而加速单价分子胶药物在效力、选择性及合成可行性方面的系统性发现与协同优化。根据协议条款，Orionis将负责分子胶的发现与优化工作，而基因泰克将负责后期的临床前与临床开发、监管申报及商业化。Orionis将获得1.05亿美元的预付款，并有资格获得总额可能超过20亿美元的潜在研究、开发、商业化等里程碑款项。潜在首款！强生单抗获FDA咨询委员会支持强生（Johnson & Johnson）公司今日宣布，美国FDA肿瘤药物咨询委员会（ODAC）以6票赞成、2票反对的结果，支持Darzalex faspro（daratumumab & hyaluronidase）单药用于治疗成人高风险冒烟性多发性骨髓瘤（HR-SMM）。根据新闻稿，如果获批，Darzalex faspro将成为首个可能延缓或预防进展为多发性骨髓瘤（MM）的疗法。SMM是多发性骨髓瘤的前期无症状阶段，可能发展为活动性多发性骨髓瘤，目前尚无获批的治疗方案。不过新近研究显示，有高风险进展为MM的患者可能从早期治疗中获益。Darzalex faspro由强生和Genmab联合开发，是首款可以通过皮下注射给药的抗CD38抗体，将患者接受治疗的时间从几个小时缩短到几分钟。Darzalex faspro获得美国FDA批准用于多发性骨髓瘤的9个适应症，其中4个适应症用于符合或不符合移植条件的新确诊多发性骨髓瘤患者的一线治疗。委员会审查了AQUILA研究的数据，这是一项3期、随机、开放标签试验，评估了Darzalex faspro与标准疗法（SoC）积极监测在HR-SMM患者中的疗效和安全性。ODAC基于AQUILA研究中无进展生存期的积极结果和临床获益给出推荐。口服小分子抑制剂获FDA突破性疗法认定Belite Bio今日宣布，美国FDA已授予tinlarebant治疗Stargardt病（STGD1）的突破性疗法认定（BTD）。FDA授予tinlarebant该认定主要是基于关键性3期DRAGON临床试验的中期分析结果，数据显示tinlarebant具有良好的疗效和安全性。Tinlarebant是一种每日一次的口服RBP4小分子抑制剂，旨在作为早期干预手段，用于维持STGD1及地图状萎缩（GA）患者视网膜组织的健康和完整性。根据新闻稿，目前FDA尚未批准用于治疗STGD1的药物，也未批准任何口服药物用于治疗GA。因此，如果获批，tinlarebant将成为一款创新的口服疗法，以应对STGD1和GA两种疾病中尚未满足的医疗需求。参考资料：[1] Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis. Retrieved May 21, 2025 from https://www.businesswire.com/news/home/20250520452648/en/Endeavor-BioMedicines-Presents-New-Clinical-Findings-From-Post-Hoc-Analysis-of-Phase-2a-Clinical-Trial-Evaluating-ENV-101-in-Patients-with-Idiopathic-Pulmonary-Fibrosis[2] U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma. Retrieved May 21, 2025 from https://www.prnewswire.com/news-releases/us-fda-oncologic-drugs-advisory-committee-votes-in-favor-of-the-benefit-risk-profile-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-high-risk-smoldering-multiple-myeloma-302461151.html[3] Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease. Retrieved May 21, 2025 from https://www.globenewswire.com/news-release/2025/05/21/3085441/0/en/Belite-Bio-Announces-FDA-Granting-of-Breakthrough-Therapy-Designation-for-Tinlarebant-for-the-Treatment-of-Stargardt-Disease.html[4] Orionis Biosciences Announces Strategic Partnership with Genentech to Discover and Develop Molecular Glue Class Medicines for Cancer. Retrieved May 21, 2025 from https://www.businesswire.com/news/home/20250521306347/en/Orionis-Biosciences-Announces-Strategic-Partnership-with-Genentech-to-Discover-and-Develop-Molecular-Glue-Class-Medicines-for-Cancer免责声明：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：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期引进/卖出

2025-05-20

·endeavorbiomedicines.com

Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis

Findings presented at the American Thoracic Society 2025 International Conference corroborate previous findings and provide important new clinical evidence supporting ENV-101 SAN DIEGO – May 20, 2025 – Endeavor BioMedicines (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today presented a post hoc analysis from the completed Phase 2a clinical trial of its lead investigational therapy, ENV-101 (taladegib). Results demonstrated a significant reduction in pulmonary vessel volume, a significant increase in lung volume, and a trend towards reduced lung fibrosis for idiopathic pulmonary fibrosis (IPF) patients treated with ENV-101 for 12 weeks vs. placebo. The analysis utilized Qureight’s deep learning-based computed tomography (CT) analytics technologies and was presented in a poster presentation at the American Thoracic Society (ATS) 2025 International Conference. Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF. “These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease,” said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. “We are grateful to the Qureight team for partnering with us on this important analysis.” The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18). Key Results from the Post Hoc Analysis Presented at ATS 2025 Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87). Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64). Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28). “We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8,” said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. “Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight’s deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine.” About the ENV-101 Phase 2a Clinical Trial Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile. About the WHISTLE-PF Trial Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound’s safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines’ investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company’s second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X. Audra Friis Sam Brown, Inc. 917-519-9577 audrafriis@sambrown.com

临床2期临床结果

2025-02-10

·药明康德

再达3期试验主要终点，突破性小分子疗法即将递交上市申请

▎药明康德内容团队编辑勃林格殷格翰（Boehringer Ingelheim）公司今天宣布，该公司的在研疗法nerandomilast，在3期临床试验FIBRONEER-ILD中达到主要终点，与安慰剂相比，在第52周时改善用力肺活量（FVC）与基线相比的绝对变化值。FVC是衡量肺功能的关键指标之一。基于这些结果，该公司计划向美国FDA和全球其它监管机构提交nerandomilast治疗渐进性肺纤维化（PPF）的新药申请。 Nerandomilast是一种偏向抑制磷酸二酯酶4B（PDE4B）的口服小分子抑制剂，具有抗炎症和抗纤维化的双重作用。该药物的临床开发计划包括两项3期研究——针对特发性肺纤维化（IPF）患者的FIBRONEER-IPF试验以及针对渐进性肺纤维化患者的FIBRONEER-ILD试验。2022年，它获得美国FDA授予的突破性疗法认定，用于治疗IPF。 PDE4是磷酸二酯酶（PDE）家族的一员，包含4个亚型（PDE4A-PDE4D），可通过特异性水解cAMP而调控促炎、抗炎细胞因子的产生。研究发现，抑制PDE4的活性可以使细胞内cAMP水平升高，激活蛋白激酶A（PKA），从而抑制NFκB和NFAT等信号通路而减少下游细胞因子和趋化因子的释放，因此以PDE4为靶点的疗法有望治疗多种炎症相关疾病。其中，PDE4B在控制钙诱导的钙释放（CICR）过程方面发挥作用，优先抑制PDE4B可维持治疗肺纤维化的疗效，同时避免某些不良事件。然而，PDE4的4种亚型的活性位点具有高度相似性，大多数PDE4抑制剂无法区分不同亚型。勃林格殷格翰的这款抑制剂在靶点选择性上有着显著优势——它对于PDE4B具有优先的抑制作用。初步数据显示，FIBRONEER系列试验在安全性和耐受性方面总体与2期特发性肺纤维化研究保持一致，总体不良事件与安慰剂组相当。 ▲Nerandomilast分子结构（图片来源：PubChem）去年9月，勃林格殷格翰宣布nerandomilast已经在治疗IPF的3期临床试验FIBRONEER-IPF中达到主要终点，显著改善IPF患者的肺功能。新闻稿指出，这是IPF领域十年来达到主要终点的首个3期临床试验。FIBRONEER-IPF和FIBRONEER-ILD的详细数据将在今年晚些时候公布。 IPF是最常见的进行性纤维化间质性肺病（ILD）之一。IPF的症状包括活动时呼吸困难、持续干咳、胸部不适、疲劳和虚弱，影响全球约300万人。该疾病主要影响50岁以上的患者，并影响男性患者多于女性。除了IPF之外，某些类型的ILD患者可能会出现称为进行性肺纤维化的表型。PPF的定义是患者出现呼吸道症状恶化，并带有疾病进展的生理和放射学特征。在治疗IPF和PPF领域，勃林格殷格翰之外，PureTech Health去年宣布，在研氘代小分子药物deupirfenidone在2b期临床试验中达到主要终点，显著减少患者FVC的下降幅度。百时美施贵宝（Bristol Myers Squibb）公司开发的口服溶血磷脂酸受体1（LPA1）拮抗剂BMS-986278，在PPF患者中进行的2期临床试验中也显著改善了患者的肺功能。此外，研发人员已经不满足于延缓患者肺功能下降的速度，转向开发逆转IPF疾病进程的药物。连续创业者John Hood博士去年在接受药明康德内容团队采访时表示，他联合创建的Endeavor Biomedicines公司的在研疗法ENV-101，在2a期临床试验中展现出逆转IPF疾病进程的能力。John Hood博士说：“这是以前从未观察到的进展。我们相信这不但是针对IPF的重要进展，也有潜力为其它致命纤维化疾病带来突破。” ▲Endeavor Biomedicines的首席执行官John Hood博士（图片来源：药明康德内容团队）相关阅读：超1亿美元助力！逆转疾病进程，创新疗法如何让人们活得更久、更好 ▲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] Boehringer widens fibrosis drug’s approval path after boosting lung function in 2nd phase 3 trial. Retrieved February 10, 2025, from https://www.fiercebiotech.com/biotech/boehringer-widens-fibrosis-drugs-potential-use-after-boosting-lung-function-2nd-phase-3 [2] Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER™-ILD, in progressive pulmonary fibrosis. Retrieved February 10, 2025, from https://www.globenewswire.com/news-release/2025/02/10/3023409/0/en/Boehringer-s-nerandomilast-meets-primary-endpoint-in-Phase-III-study-FIBRONEER-ILD-in-progressive-pulmonary-fibrosis.html [3] Boehringer’s nerandomilast meets primary endpoint in pivotal phase-III FIBRONEER™-IPF study. Retrieved February 10, 2025, from https://www.globenewswire.com/news-release/2024/09/16/2946446/0/en/Boehringer-s-nerandomilast-meets-primary-endpoint-in-pivotal-phase-III-FIBRONEER-IPF-study.html 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

突破性疗法临床3期临床结果

100 项与 Taladegib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10671	-	-	DB12550

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
进行性纤维化间质性肺病	临床2期	美国	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	阿根廷	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	澳大利亚	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	奥地利	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	比利时	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	加拿大	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	法国	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	德国	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	爱尔兰	Endeavor BioMedicines, Inc	2024-11-15
进行性纤维化间质性肺病	临床2期	意大利	Endeavor BioMedicines, Inc	2024-11-15

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临床结果

适应症

分期

评价

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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


NCT04968574 (Company_Website) 人工标引	临床2期	特发性肺纤维化	-	ENV-101 (taladegib)	鹹鏇顧觸憲範艱醖窪遞(遞餘選選衊觸蓋鏇範製) = 憲鹽簾襯簾齋夢願鬱憲餘膚鏇鑰網築鹽齋遞願 (壓願膚廠範壓獵製獵壓 ) 更多	积极	2025-05-20
				Placebo	鹹鏇顧觸憲範艱醖窪遞(遞餘選選衊觸蓋鏇範製) = 積憲齋衊夢鏇齋選蓋範餘膚鏇鑰網築鹽齋遞願 (壓願膚廠範壓獵製獵壓 ) 更多
NCT04968574 (ENV-IPF-101, ATS2025)	临床2期	特发性肺纤维化 lung volume \| vessel volume \| fibrosis extent ... 更多	34	ENV-101 200 mg	蓋鑰夢範壓繭糧獵範簾(範範顧繭築壓餘鏇窪築) = 醖襯夢願顧鏇蓋觸繭鬱製網繭廠積繭選製餘艱 (壓築願選夢製糧築範夢 ) 更多	积极	2025-05-16
				Placebo	蓋鑰夢範壓繭糧獵範簾(範範顧繭築壓餘鏇窪築) = 夢艱觸膚選憲範夢鹹蓋製網繭廠積繭選製餘艱 (壓築願選夢製糧築範夢 ) 更多
NCT04968574 (ENV-IPF-101, ATS2024) 人工标引	临床2期	特发性肺纤维化	41	ENV-101	膚壓夢衊選蓋醖築鏇遞(鏇齋膚壓積鑰衊顧窪廠) = The most common ENV-101-related adverse events were dysgeusia (alterations in taste; 57%), alopecia (52%) and muscle spasms (43%), which were all mild to moderate in severity. 艱壓繭鬱憲範糧範願鏇 (醖醖範獵範鹹齋夢繭窪 ) 更多	积极	2024-05-19
ENV-101 (EADV2023)	临床2期	基底细胞癌 PTCH1 Loss of Function mutations	44	Taladegib 200 mg	鑰顧網範鬱醖簾製簾鹹(繭遞繭鏇鏇憲繭鬱夢鏇) = Patient reported alopecia during the study 壓鹽簾鹹網鹽憲蓋衊鑰 (鏇鏇繭廠構憲鏇蓋糧醖 ) 更多	积极	2023-10-11
				Vismodegib
NCT02784795 (I6F-MC-JJCD, Pubmed \| Invest New Drugs)	临床1期	转移性实体瘤	63	Crenigacestat + Taladegib	鹽網壓齋鹹鏇淵選構膚(蓋築鬱壓遞齋願餘簾齋) = 鬱獵窪獵壓簾願繭膚齋築鑰願夢遞廠網構夢夢 (餘網築衊壓鏇選鹹獵獵 )	不佳	2021-03-08
				Crenigacestat + LY3023414	鹽網壓齋鹹鏇淵選構膚(蓋築鬱壓遞齋願餘簾齋) = 願淵醖艱製醖選鹽獵製築鑰願夢遞廠網構夢夢 (餘網築衊壓鏇選鹹獵獵 ) 更多
NCT01919398 (CTgov)	临床1期	晚期恶性实体瘤 \| 晚期癌症	19	LY2940680 (Cohort 1: 100 mg LY2940680)	窪選餘膚醖窪餘艱餘願 = 膚餘獵餘壓積窪夢醖遞顧艱積簾範網糧觸鹹繭 (鹽齋醖壓艱獵製艱鑰餘, 窪壓選簾鏇顧鬱簾淵憲 ~ 築憲糧艱鹹膚構廠襯夢) 更多	-	2019-09-11
				LY2940680 (Cohort 2: 200 mg LY2940680)	窪選餘膚醖窪餘艱餘願 = 艱築願廠鑰網壓醖顧蓋顧艱積簾範網糧觸鹹繭 (鹽齋醖壓艱獵製艱鑰餘, 襯築鏇製淵膚窪憲壓觸 ~ 範網襯製蓋觸範範糧窪) 更多
NCT01746745 (CTgov)	临床1期	-	6	[^14C]-LY2940680	願襯觸醖艱製築憲遞鏇(觸衊築鏇廠廠糧觸觸蓋) = 廠窪選遞鏇遞鏇壓遞襯繭積衊範廠壓鹹襯選積 (糧夢顧積觸衊願艱網簾, 2.81) 更多	-	2019-07-22
NCT01919398 (Pubmed \| Invest New Drugs) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	19	taladegib	遞積鬱獵淵襯廠衊獵願(鬱鏇獵鏇淵積壓獵觸餘) = No dose-limiting toxicities (DLTs) were observed at doses of 100 mg or 200 mg; 3 of the 9 patients evaluable for DLTs at the 400 mg dose level experienced DLTs (thrombocytopenia: 1; decreased appetite: 2) 積夢壓醖鹹壓憲齋淵膚 (範膚遞夢範觸範憲築顧 ) 更多	积极	2018-08-01
NCT01226485 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	基底细胞癌 \| 晚期癌症	84	LY2940680	構夢範觸餘糧衊鬱醖範(艱膚範選製構顧齋獵糧) = 製壓膚獵夢遞鹹獵廠選鑰簾餘糧夢築齋襯製窪 (選簾鹹憲鹽鏇積艱淵衊 ) 更多	积极	2018-05-01