A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants

The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants

开始日期2024-09-19

申办/合作机构

Bristol Myers Squibb Co.

CTIS2023-503699-25-00 / Recruiting

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis - IM0271015

开始日期2024-07-29

申办/合作机构

Bristol Myers Squibb Co.

CTIS2023-503697-21-01 / Recruiting

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis - IM027068

开始日期2024-07-29

申办/合作机构

Bristol Myers Squibb Co.

100 项与 Admilparant 相关的临床结果

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100 项与 Admilparant 相关的转化医学

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100 项与 Admilparant 相关的专利（医药）

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项与 Admilparant 相关的文献（医药）

2024-09-01·CURRENT OPINION IN PULMONARY MEDICINE

Evidence from recent clinical trials in fibrotic interstitial lung diseases

Review

作者: Valenzuela, Claudia ; Cottin, Vincent

Purpose of review:

Idiopathic pulmonary fibrosis (IPF) is the prototype of fibrosing interstitial lung diseases. It is mirrored by progressive pulmonary fibrosis (PPF), an umbrella term which characterizes disease behavior of various fibrotic interstitial lung diseases with irreversible progression, accounting for loss of lung function, exercise intolerance and respiratory failure leading to early mortality. Pirfenidone and nintedanib halve the decline in lung function but do not halt disease progression.

Recent findings:

Since the publication in 2014 of pivotal pirfenidone and nintedanib studies, a number of clinical trials were conducted, many of them did not reach their primary endpoints. In IPF, promising phase 2 trials were followed by large phase 3 trials that did not confirm a favorable efficacy to tolerability favorable profile, including those with ziritaxestat, an autotaxin-1 inhibitor, zinpentraxin-alpha (human recombinant pentraxin-2), and the monoclonal antibody pamrevlumab targeting connective tissue growth factor. Nevertheless, newer compounds that hold promise are currently being evaluated in phase 3 or phase 2b randomized controlled trials, including: nerandomilast, a preferential phosphodiesterase 4B inhibitor; admilparant, a lysophosphatidic acid receptor antagonist; inhaled treprostinil, a prostacyclin agonist; and bexotegrast, a dual-selective inhibitor of αvβ6 and αvβ1 integrins. Nerandomilast, admilparant, inhaled treprostinil, and inhaled AP01 (pirfenidone), are currently studied in patients with PPF.

Summary:

Despite recent frustrating negative results, there is a growing portfolio of candidate drugs developed in both IPF and PPF.

2022-03-01·Toxicology and applied pharmacology3区 · 医学

Mechanism of hepatobiliary toxicity of the LPA1 antagonist BMS-986020 developed to treat idiopathic pulmonary fibrosis: Contrasts with BMS-986234 and BMS-986278

3区 · 医学

Article

作者: Murphy, Brian J ; Lehman-McKeeman, Lois ; Cheng, Peter T W ; Sivaraman, Lakshmi ; Davis, Myrtle ; Gill, Michael W

In a Phase 2 clinical trial, BMS-986020, a lysophosphatidic acid receptor-1 (LPA₁) antagonist, produced hepatobiliary toxicity (increased ALT, AST, and ALP; cholecystitis) and increases in plasma bile acids (BA). Nonclinical investigations conducted to identify a potential mechanism(s) for this toxicity examined BMS-986020 and two LPA₁ antagonists structurally distinct from BMS-986020 (BMS-986234 and BMS-986278). BMS-986020 inhibited hepatic BA efflux transporters BSEP (IC₅₀ 1.8 μM), MRP3 (IC₅₀ 22 μM), and MRP4 (IC₅₀ 6.2 μM) and inhibited BA canalicular efflux in human hepatocytes (68% at 10 μM). BMS-986020 inhibited mitochondrial function (basal and maximal respiration, ATP production, and spare capacity) in human hepatocytes and cholangiocytes at ≥10 μM and inhibited phospholipid efflux in human hepatocytes (MDR3 IC₅₀ 7.5 μM). A quantitative systems toxicology analysis (DILIsym®), considering pharmacokinetics, BA homeostasis, mitochondrial function, oxidative phosphorylation, and reactive intermediates performed for BMS-986020 recapitulated clinical findings ascribing the effects to BA transporter and mitochondrial electron transport chain inhibition. BMS-986234 and BMS-986278 minimally inhibited hepatic BA transporters (IC₅₀ ≥20 μM) and did not inhibit MDR3 activity (IC₅₀ >100 μM), nor did BMS-986234 inhibit BA efflux (≤50 μM) or mitochondrial function (≤30 μM) (BMS-986278 not evaluated). Multiple mechanisms may be involved in the clinical toxicity observed with BMS-986020. The data indicate that this toxicity was unrelated to LPA₁ antagonism since the mechanisms that likely influenced the adverse clinical outcome of BMS-986020 were not observed with equipotent LPA₁ antagonists BMS-986234 and BMS-986278. This conclusion is consistent with the lack of hepatobiliary toxicity in nonclinical and clinical safety studies with BMS-986278.

2022-03-01·Toxicology and applied pharmacology3区 · 医学

Structure dependence and species sensitivity of in vivo hepatobiliary toxicity with lysophosphatidic acid receptor 1 (LPA1) antagonists

3区 · 医学

Article

作者: Chadwick, K D ; Sivaraman, L ; Gill, M ; Nelson, D M

BMS-986020, BMS-986234 and BMS-986278, are three lysophosphatidic acid receptor 1 (LPA₁) antagonists that were or are being investigated for treatment of idiopathic pulmonary fibrosis (IPF). Hepatobiliary toxicity (elevated serum AST, ALT, and ALP, plasma bile acids [BAs], and cholecystitis) was observed in a Phase 2 clinical trial with BMS-986020, and development was discontinued. In dogs and rats, the species used for the pivotal toxicology studies, there was no evidence of hepatobiliary toxicity in the dog while findings in the rat were limited to increased plasma BAs levels (6.1× control), ALT (2.9×) and bilirubin (3.4×) with no histopathologic correlates. Since neither rats nor dogs predicted clinical toxicity, follow-up studies in cynomolgus monkeys revealed hepatobiliary toxicity that included increased ALT (2.0× control) and GLDH (4.9×), bile duct hyperplasia, cholangitis, cholestasis, and cholecystitis at clinically relevant BMS-986020 exposures with no changes in plasma or liver BAs. This confirmed monkey as a relevant species for identifying hepatobiliary toxicity with BMS-986020. In order to assess whether the toxicity was compound-specific or related to LPA₁ antagonism, two structurally distinct LPA₁ antagonists (BMS-986234 and BMS-986278), were evaluated in rat and monkey. There were no clinical or anatomic pathology changes indicative of hepatobiliary toxicity. Mixed effects on plasma BAs in both rat and monkey has made this biomarker not a useful predictor of the hepatobiliary toxicity. In conclusion, the nonclinical data indicate the hepatobiliary toxicity observed clinically and in monkeys administered BMS-986020 is compound specific and not mediated via antagonism of LPA₁.

项与 Admilparant 相关的新闻（医药）

2024-08-30

·CPHI制药在线

靶点 | 特发性肺纤维化治疗药物前瞻

特发性肺纤维化（IPF）是一种慢性、进展性的间质性肺疾病，主要症状为进行性加重的呼吸困难，肺功能下降，持续性干咳、胸闷、疲劳等，急加重时可出现低氧血症和急性呼吸衰竭。 IPF预后较差，从诊断开始中位生存期仅2~3年。虽然IPF被认定为“罕见”疾病，但亚洲地区的发病率已达每年每10万人1.2~4.16例，欧洲和北美地区每年每10万人2.8~19例），全世界大约已有300万例IPF患者。遗憾的是，IPF由于发病机制复杂，目前全球范围内仅有吡非尼酮和尼达尼布被批准用于治疗。其中吡非尼酮是一种多效性的吡啶化合物，可调节转化生长因子-β(TGF-β)、结缔组织生长因子(CTGF)、血小板源生长因子(PDGF)和肿瘤坏死因子(TNF-α)，具有抗炎、抗氧化及抗纤维化的作用。非尼酮能够显著地延缓用力呼气肺活量下降速率（FVC），可能在一定程度上降低病死率。尼达尼布是一种多靶点酪氨酸激酶抑制剂，能够抑制血小板衍化生长因子受体、血管内皮生长因子受体（VEGFR）及成纤维细胞生长因子受体。尼达尼布能够显著地减少IPF患者FVC下降的绝对值，一定程度上缓解疾病进程。由于两款药物都会产生显著不良反应，从而限制临床给药及其疗效潜力发挥，因此抗IPF药物治疗手段仍亟待开发。目前，研发主要集中于以下靶点。 PDE是一个酶家族，由11个家族亚型成员，其主要负责催化第二信使环状核苷酸（cAMP和cGMP）水解，进而对细胞代谢发挥重要作用。研究发现，细胞内cAMP水平过低与呼吸系统疾病以及以免疫系统失调为特征的疾病（包括银屑病和其他慢性炎症）的发病机制有关。而细胞内的cAMP水平主要受腺苷酸环化酶（AC）和磷酸二酯酶4（PDE4）的活性控制。受到刺激时，AC通过将ATP转化为cAMP来提高cAMP水平。因此，开发PDE4抑制剂开始受到重视。勃林格殷格翰开发的一款口服PDE4B抑制剂BI 1015550已处于临床III期，拟开发适应症为IPF。BI 1015550对PDE4B具有优先的酶促抑制作用。PDE4B在控制钙诱导的钙释放过程方面发挥作用，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。II期临床研究表明，BI 1015550在12周治疗的临床试验中表现出较好的潜力，延缓了IPF患者的肺功能下降率。在延缓IPF患者肺功能下降速度方面，BI 1015550优于安慰剂的概率超过98%。国内海思科的HSK44459刚于近日获得临床试验默示许可。HSK44459是一种高选择性PDE4B抑制剂，可以通过抑制炎性因子的渗出和成纤维细胞的增殖活化，达到抗炎和抗纤维化的作用。HSK44459预期在保留抗炎效果的基础上，能减少胃肠道、中枢神经等不良反应。研究发现，LPA1能促进肺泡上皮细胞凋亡，并诱导成纤维细胞趋化至损伤部位，增强其增殖和胶原蛋白分泌以及对细胞凋亡的抵抗力。LPA1水平的升高和LPA1的激活与肺纤维化的发病机制相关。一项临床前研究发现，拮抗LPA1的作用可能有利于治疗肺损伤和肺纤维化。因此业界将LPA1定位为IPF和其他纤维化疾病有前景的治疗靶点。 BMS的BMS-986278是一种潜在FIC小分子LPA1拮抗剂，目前正作为一种新型抗纤维化治疗药物在IPF患者中进行评估。研究结果显示，与安慰剂相比，每天服用两次60 mg的BMS-986278并持续26周，可以让IPF患者的预测用力肺活量百分比（ppFVC）降低69%。 CTGF是1991年Bradham等首先在人脐静脉内皮细胞的条件培养基中发现的，CTGF对成纤维细胞具有促细胞增殖、迁移及分化等作用。研究发现，IPF患者的CTGF明显增加，因此，抗CTGF抗体药物可以通过中和结缔组织生长因子，达到治疗IPF的目的。 Pamrevlumab是由Fibrogen（珐博进）研发的一种全人源单克隆抗体，是一种CTGF抑制剂。Pamrevlumab用于治疗IPF的III期临床研究正在进行中。目前，IPF整体疾病认知率较低，早期鉴别诊断困难，确诊后中位生存期仅2~3年，被誉为“不是癌症的癌症”，令人遗憾的是，由于具体的病因至今尚未明确，在过去数年里，针对IPF的治疗方法几乎没有新的突破和创新，传统药物并不能逆转肺纤维化进程，只能延缓或稳定疾病进展，改善肺功能，且有一部分患者因不良反应无法耐受治疗。IPF新疗法的开发，已到了十分迫切的程度。参考来源： 1、Herrmann FE et al. (2022) BI 1015550 is a PDE4B Inhibitor and a Clinical Drug Candidate for the Oral Treatment of Idiopathic Pulmonary Fibrosis. Front Pharmacol. doi: 10.3389/fphar.2022.838449. 2、Schaefer CJ et al. Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev 2011;20: 85–97. 3、Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase 2 Study，Retrieved Sep 12, 2023 fromhttps://www.businesswire.com/news/home/20230908930377/en/. 4、Esther SK, Gillian MK. Pirfenidone: A review of its use in idiopathic pulmonary fibrosis. Drugs. 2015;75:219–30. 内容来源于网络，如有侵权，请联系删除。

申请上市优先审批

2024-08-29

·新药前沿

IPF也疯狂：新药开发“三剑客”突围

First in Class类新药虽是全球生物医药公司的最高追求，但对于国内多数医药公司来说，以目前的实力可能还难以企及。follow策略仍旧是目前国内多数创新药开发者的首选。而在现实中，国内企业仍旧面临着follow（信息、研发等）速度慢、动态评估不科学和关键节点决策不果断等问题（或风险）。【中国follow式创新药系列】将通过一些案例的介绍，希望能够给国内生物医药公司follow First in Class类新药提供经验和思考。特发性肺纤维化（IPF）是一种主要发生在老年人群中的慢性、进行性、不可逆、纤维化和致命的慢性纤维化性间质性肺炎。全世界约有300万人患有此病，目前国内缺乏IPF发病率及患病率数据，在我国预计有40-60万患者，每年发病率新增11%。 IPF病因不明，病因多样，治疗方法不多，预后差，因此该领域新药研发远远不能满足临床需求。争食两强重磅市场份额自2014年10月FDA相续批准基因泰克（罗氏）的Esbriet（吡非尼酮）和勃林格殷格翰的Ofev（尼达尼布）用于治疗特发性肺纤维化（IPF），两强之间的市场份额之争异常激烈。以“孤儿药”地位获批并不影响Esbriet和Ofev能到达“重磅炸弹”级销售额的能力。Esbriet在美国失去独占保护的2021年实现了10.4亿美元的销售额（其中约7.32亿美元来自美国市场），而即将于2025年在美国失去专利保护的Ofev在2023年全球销售额更是达到35.10亿欧元（约38亿美元）。目前，在美国有4款Ofev仿制药获得FDA暂时性批准(Tentative Approval)等待原研专利到期后上市，而Esbriet 仿制药已上市的竞争者多达7家。在中国，据米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端吡非尼酮、尼达尼布合计销售额超过9亿元，同比增长57.06%。两款产品快速增长的市场，再加上在中国已失去专利保护，同样面临着仿制药的激烈竞争：尼达尼布仿制药获批上市6家（齐鲁、人福普克、江苏万高、四川科伦、江苏豪森、石药恩必普）。另外还有瑞阳制药、沈阳红旗正在ANDA审评中。尽管吡非尼酮仿制药目前仅有北京凯因科技获批上市，不过正在ANDA审评中的厂家同样不少（包括重庆赛维、成都倍特药业、四川依科制药、山东华铂凯盛/安徽泰恩康、江苏知原、浙江金华康恩贝），此外，在吡非尼酮改良药物方面，浙江金华康恩贝和越洋医药分别正在开发吸入用吡非尼酮溶液和吡非尼酮双释片。有意思的是，还有3家公司正在开发吡非尼酮的me-too/better类药物：广州嘉越的舒非尼酮、广东东阳光的伊非尼酮和爱科百发AK3280。现有疗法局限性尽管机制不完全相同，吡非尼酮通过抑制细胞因子转化生长因子β(TGF-β)来抑制纤维化过程。而尼达尼布可广泛抑制成纤维细胞和肌成纤维细胞中的下游信号通路。这两种药物都能抑制成纤维细胞增殖、阻碍胶原蛋白的产生并减少纤维化介质的产生，有效改善肺功能和减缓疾病进展，但不可避免的是吡非尼酮和尼达尼布都会产生显著的不良反应，从而限制临床给药及其全部疗效潜力。如近期发表于《欧洲临床药理学杂志》的一项真实世界研究的系统评价与荟萃分析显示，吡非尼酮和尼达尼布的不良反应发生率分别高达56.4%和69.7%，因不良反应中断治疗率分别为16.6%和16.2%，IPF相关死亡率分别为13.4%和7.2%，全因死亡率分别为20.1%和16.6%。 IPF的发病机制是多方面的且目前尚未完全了解，再加上非尼酮和尼达尼布临床治疗的局限性，因此该领域更具疗效和安全性的新药研发对满足IPF临床未满足需求更加必需和紧迫。新药开发初露锋芒 IPF新药研发尽管屡屡遭遇失败挫折，但近期已有3款新机制的项目进入到临床试验晚期阶段，如能成功该领域有望取得新的突破。 Nerandomilast：PDE4B抑制剂勃林格殷格翰开发的Nerandomilast (BI 1015550) 是一种口服的选择性磷酸二酯酶4B (PDE4B) 抑制剂。抑制PDE4可提高细胞内环磷酸腺苷(cAMP)水平，减轻炎症和纤维化相关的炎症，这表明，激活cAMP通路可为治疗IPF提供新的靶点。除了抗炎作用外，Nerandomilast还在临床前模型中表现出抗纤维化作用，因为Nerandomilast抑制了TGF-β刺激的成纤维细胞转化为肌成纤维细胞。 Nerandomilast在IPF患者中开展的II期试验表明，该药物在预防肺功能下降方面取得了良好的效果，且安全性良好。然而，这项概念验证研究的局限性在于其持续时间为12周，样本量相对较小（147名患者，按2:1的比例随机分配接受BI1015550或安慰剂）。腹泻是所有患者（>10%的患者）中报告最多的事件，所有事件均报告为非严重事件。勃林格殷格翰目前正在进行Nerandomilast治疗IPF和进行性肺纤维化 (PPF) 的III期试验。国内海思科和人福医药也在布局选择性PDE4B抑制剂，其中海思科8月初发布公告称，其开发的HSK44459用于间质性肺疾病IND申请获得CDE批准，即将开展临床试验。 BMS-986278：LPA1拮抗剂百时美施贵宝于2011年斥资3.25亿美元收购Amira Pharmaceuticals，从而获得了强效小分子溶血磷脂酸（LPA）1拮抗剂候选药物BMS-986278。LPA通过溶血磷脂酸受体1（LPAR1）诱导成纤维细胞迁移/积聚和血管渗漏，从而促进纤维化的进展。BMS-986278可阻断循环和局部的成纤维细胞被招募至损伤部位；抑制上皮细胞通过上皮间质转化（EMT）分化为成纤维细胞。 BMS-986278的II期研究表明，与安慰剂相比，BMS-986278治疗26周可将预测用力肺活量百分比(ppFVC)的下降率降低62%。BMS-986278在两个治疗组中均耐受性良好，不良事件发生率（包括胃肠道副作用发生率）和治疗中断率与安慰剂组相当。 BMS-986278治疗IPF 的III期试验正在进行中。而安进同类项目AMG 670紧随其后也正在进行IIb期临床试验。 Bexotegrast：αvβ6和αvβ1整合素双选择性抑制剂 Pliant Therapeutics开发的Bexotegrast(PLN-74809)是一种口服小分子αvβ6和αvβ1整合素双选择性抑制剂。αvβ6和αvβ1整合素在正常组织中的表达水平非常低，但在特发性肺纤维化患者的肺组织中表达上调。这两种整合素都是TGF-β的激活剂，可导致胶原蛋白生成增加，并最终导致这些组织纤维化。通过阻断αvβ6和αvβ1对TGF-β的激活，Bexotegrast可能减缓并可能阻止此类患者群体的纤维化进展。 IIa期研究表明，Bexotegrast治疗的患者总肺胶原减少，而安慰剂组的总肺胶原增加，表明纤维化可能逆转。与安慰剂组相比，接受Bexotegrast治疗的患者在所有时间点均表现出用力肺活量(FVC)改善和咳嗽严重程度降低。Bexotegrast耐受性良好，没有药物相关的严重不良事件(SAE)且没有停药。 Bexotegrast治疗IPF 的II/III期试验正在进行中。除上述项目外，目前还有多达十多种不同作用机制的IPF新药进入到临床试验阶段，期待未来有更多新突破。注：本文已刊载于8月22日《医药经济报》往期推荐 01 Nav1.8抑制剂fast-follow者恒瑞快速调转船头 02 吸入PDE3/4抑制剂fast-follow凑齐3家：正大天晴领跑，恒瑞延缓后被海思科追赶 03 DPP1抑制剂fast-follow者海思科的完美“变现” 04 神经疼痛新靶点AAK1：IIa期POC已成功，引国内多家公司fast-follow布局 05 PDE4B抑制剂fast-follow者海思科和人福，紧追勃林格殷格翰本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

孤儿药专利到期

2024-07-08

·Pharmaceutical Technology

Lilly bolsters IBD portfolio with $3.2bn Morphic acquisition

Inflammatory bowel disease, which includes crohn’s disease and ulcerative colitis, are characterised by chronic inflammation of the gastrointestinal tract. Credit: SewCreamStudio via Shutterstock. Eli Lilly has signed a definitive agreement to acquire Morphic Holding for $3.2bn, expanding its inflammatory bowel disease (IBD) portfolio. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - MORF-057 in Ulcerative Colitis Reports NPVM: Bristol-Myers Squibb Co's BMS-986278 Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Through the deal – which is expected to close in Q3 2024 – Lilly will inherit Morphic’s lead asset, MORF-057. The candidate is under investigation in two Phase II studies for ulcerative colitis and one Phase II study for Crohn’s disease. The small molecule drug inhibits α4β7, an integrin expressed on some white blood cells. With this deal, Lilly looks to challenge Takeda’s blockbuster drug Entyvio (vedolizumab), which bagged a US Food and Drug Administration (FDA) approval in April 2014 to treat IBD. Entyvio is also an α4β7 inhibitor shown to reduce inflammation in the gut and control symptoms of IBD. However, the oral format of MORF-057, compared to the intravenous and now injectable versions of Entyvio, may open up a new market opportunity for Lilly, with some patients preferring oral medications due to ease. IBD is the umbrella term for two chronic conditions: Crohn’s disease and ulcerative colitis, both of which cause inflammation in the digestive tract. GlobalData estimates that the Crohn’s and ulcerative colitis markets will be worth $25.5bn and $14.7bn by 2032, respectively. GlobalData is the parent company of Pharmaceutical Technology. See Also: How will a Labour government support the UK clinical trials industry? TLC-2716 by OrsoBio for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia): Likelihood of Approval Lilly already has an IBD drug under its belt—anti-interleukin (IL)-23 therapy Omvoh (mirikizumab), which secured FDA approval for treating ulcerative colitis in October 2023. According to GlobalData’s Pharma Intelligence Center, Omvoh will generate $939m in sales in 2030. The IBD field is quite crowded, with AbbVie ’s Humira (adalimumab) being the top earner. However, there is still a potential preference for oral drug formulations like Bristol Myers Squibb ’s (BMS) Zeposia (ozanimod), and AbbVie’s Rinvoq (upadacitinib). In the announcement accompanying the acquisition, Lilly’s chief scientific officer Daniel Skovronsky said: “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease.” This latest deal comes after a flurry of high-profile acquisitions from Lilly last year, including DICE Therapeutics for $2.4bn in June 2023 , where it inherited a preclinical oral α4β7 programme. In October 2023, Lilly signed a definitive agreement for the acquisition of radiopharmaceutical company POINT Biopharma for an all-in cash price of $1.4bn. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. 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上市批准并购临床2期生物类似药

100 项与 Admilparant 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
进行性肺纤维化	临床3期	美国	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	中国	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	日本	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	阿根廷	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	澳大利亚	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	奥地利	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	比利时	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	巴西	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	加拿大	Bristol Myers Squibb Co.	2023-10-25
进行性肺纤维化	临床3期	智利	Bristol Myers Squibb Co.	2023-10-25

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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


NCT04308681 (Pubmed \| Am J Respir Crit Care Med) 人工标引	临床2期	特发性肺纤维化 \| 进行性肺纤维化	-	Admilparant 30mg (IPF)	鏇壓廠積網製構願遞觸(膚窪繭壓鬱選製範鹹襯) = Diarrhea occurred at similar frequencies in admilparant arms versus placebo 蓋簾積鹹簾築製蓋鹹襯 (夢蓋積簾鹹遞壓鏇窪簾 ) 更多	积极	2024-10-11
				Admilparant 60mg (IPF)
NCT04308681 (ALOFT, Corporate Publications) 人工标引	临床2期	进行性肺纤维化	122	BMS-986278 30 mg	壓選醖糧膚鏇鑰糧築鑰(膚繭鏇夢繭鏇鑰築願網) = 醖衊築窪遞淵壓製鹽衊憲糧繭壓鑰衊餘艱鑰鑰 (積窪簾憲鏇構簾網淵顧 ) 更多	积极	2023-09-09
				BMS-986278 30 mg	壓選醖糧膚鏇鑰糧築鑰(膚繭鏇夢繭鏇鑰築願網) = 艱齋夢壓顧構網壓醖遞憲糧繭壓鑰衊餘艱鑰鑰 (積窪簾憲鏇構簾網淵顧 ) 更多
NCT04308681 (Corporate Publications) 人工标引	临床2期	特发性肺纤维化	276	BMS-986278 30 mg	鏇遞艱網鑰艱憲繭製鹹(獵鹽積鏇鑰獵積鹽獵網) = 範膚淵壓壓製獵鬱積獵觸積醖顧顧蓋範鏇鬱壓 (糧構蓋網衊構製餘餘憲, -1.8 ~ 1.4) 达到更多	积极	2023-05-22
				BMS-986278 60 mg	鏇遞艱網鑰艱憲繭製鹹(獵鹽積鏇鑰獵積鹽獵網) = 繭鏇獵簾窪廠鬱壓淵鑰觸積醖顧顧蓋範鏇鬱壓 (糧構蓋網衊構製餘餘憲, -0.1 ~ 3.0) 达到更多
NCT04308681 (Pubmed \| J Med Chem)	临床2期	肺纤维化	278	BMS-986278	壓範願鑰蓋築糧構築夢(製構製鬱憲構壓餘醖窪) = 遞鏇遞鏇夢醖築遞鹹鏇願淵窪齋網鹹網齋遞鬱 (憲醖鬱鏇獵艱鏇窪鑰鏇 )	-	2021-10-28
ERS2020	N/A	-	15	BMS-986278	蓋淵壓壓壓網網壓遞鹹(蓋遞選構壓遞壓鹽鏇鹹) = 鹹獵鹽憲窪鹽製餘構範鹽齋襯願鏇願糧製製襯 (網獵衊蓋遞構範艱夢鹹 )	-	2020-09-07
IM027-009 \| BMS-986278 (ERS2019)	临床1期	-	-	BMS-986278	艱鹹鏇網膚繭選願憲鬱(蓋獵夢網獵衊廠醖蓋襯) = the most common AE was headache 築構選襯膚構廠廠築遞 (鏇繭鬱繭衊鑰願築夢繭 ) 更多	积极	2019-09-28