This prescreening study is being conducted to diagnose ABPA in selected patients with asthma and to increase the potential number of eligible participants for the ongoing Study 601-0018 of PUR1900 in subjects with ABPA. See: NCT05667662.
Additionally, this prescreening study may provide information that could assist the conduct of future studies conducted by Pulmatrix.

开始日期2024-01-10

申办/合作机构

Community Pharmacology Services Ltd

[+1]

EUCTR2022-002289-33-FR / Not yet recruiting临床2期

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients with Asthma and Allergic Bronchopulmonary Aspergillosis

开始日期2023-02-01

申办/合作机构

Pulmatrix, Inc.

NCT05667662 / Terminated临床2期

Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA

The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are:
Is PUR1900 safe and well tolerated in adults with asthma and ABPA?
Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA?
Is there fungal resistance to A. fumigatus?
This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period.
Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.

开始日期2023-02-01

申办/合作机构

Pulmatrix, Inc.

100 项与 Pulmatrix, Inc. 相关的临床结果

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项与 Pulmatrix, Inc. 相关的文献（医药）

2023-06-21·The AAPS journal

Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data.

Article

作者: Templeton, Ian E ; Bergagnini-Kolev, Mackenzie ; Curran, Aidan K ; Kane, Katie

Itraconazole is a potent inhibitor of cytochrome P450 3A4 (CYP3A4), associated with numerous drug-drug interactions (DDI). PUR1900, a dry powder formulation of itraconazole for oral inhalation, results in high lung and low systemic exposure. This project used physiologically based pharmacokinetic (PBPK) modeling to assess the DDI potential of inhaled PUR1900, using midazolam as a "victim drug." The basic and mechanistic static models evaluated the DDI potential of PUR1900, assuming 5 mg of midazolam coadministration at steady-state itraconazole exposure. Subsequently, Simcyp® PBPK simulation software and pharmacokinetic data from a Phase 1 clinical trial with PUR1900 (NCT03479411) were used to optimize an existing itraconazole PBPK model. The model was applied to investigate the potential for CYP3A4 DDI when 5 mg of midazolam is co-administered with inhaled PUR1900 at a steady state in a virtual healthy population at PUR1900 doses up to 40 mg per day. The basic static and mechanistic static models suggested a strong likelihood for DDI with inhaled PUR1900. The PBPK model was consistent with PUR1900 Phase 1 trial data. The geometric mean C_max and AUC ratios of midazolam at a maximum dose of 40 mg PUR1900 were 1.14 and 1.26, respectively, indicating a minimal likelihood of DDI with inhaled PUR1900. The low systemic exposure of itraconazole when administered as PUR1900 results in minimal to no CYP3A4 inhibition, reducing the concern of drug-drug interactions. As the risk of CYP3A4 DDI is predicted to be significantly lower when itraconazole is administered via oral inhalation as PUR1900, it is likely that PUR1900 can be safely used for the treatment of pulmonary fungal infections in patients taking pharmaceuticals currently contraindicated with oral itraconazole.

2018-12-01·Pulmonary pharmacology & therapeutics3区 · 医学

Inhaled calcium salts inhibit tobacco smoke-induced inflammation by modulating expression of chemokines and cytokines

3区 · 医学

Article

作者: Kenyon, Jennifer ; Russell, Vince ; Hava, David L ; Berry, Elizabeth ; Kong, Sophanna ; Arold, Steve ; Clarke, Robert W ; Okerholm, Pamela ; Brogan, Tim ; Andreotta, Paulette W ; Woodman, Paul ; Spicer, Diane

Tobacco smoke-induced lung inflammation in patients with chronic obstructive pulmonary disease (COPD) worsens with disease progression and acute exacerbations caused by respiratory infections. Chronic therapies to manage COPD center on bronchodilators to improve lung function and inhaled corticosteroids (ICS) to help reduce the risk of exacerbations. Novel therapies are needed that reduce the underlying inflammation associated with COPD and the inflammation resulting from respiratory infections that worsen disease. The lung is lined with airway surface liquid (ASL), a rheologically active material that provides an innate defense for the airway against inhaled particulate and is continuously cleared from the airways by mucociliary clearance. The rheological properties of the ASL can be altered by changes in airway hydration and by cations, such as calcium, that interact with electronegative glycoproteins. The effect of inhaled salts on inflammation resulting from tobacco smoke exposure was studied to determine if cations could be used to alter the properties of the ASL and reduce inflammation. Inhaled calcium salts, but not sodium or magnesium salts, reduced cellular inflammation and key chemokines and cytokines that were induced by tobacco smoke exposure. Similar anti-inflammatory effects of calcium salts were observed using in vitro cultures of human monocyte derived macrophages and human bronchial epithelial cells. The data suggest that inhaled calcium salts may act broadly on both biophysical and biological pathways to reduce pulmonary inflammation.

2015-12-01·BMC pharmacology & toxicology4区 · 医学

Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model - a clinical trial

4区 · 医学

ArticleOA

作者: Rosano, M ; Hohlfeld, J M ; Kane, K ; Holz, Olaf ; Biller, H ; Hanrahan, J ; Mueller, M ; Hava, D L

BACKGROUND:

The ozone challenge model can be used to assess the efficacy of anti-inflammatory compounds in early phases of clinical drug development. PUR118, a calcium salt based formulation engineered in the iSPERSE(TM) dry powder delivery technology, is a novel anti-inflammatory drug for COPD. Here we evaluated the efficacy and safety of three doses of PUR118 in attenuating ozone-induced airway inflammation in healthy volunteers.

METHODS:

In a single-blind, phase 1B proof of concept study, 24 subjects were enrolled to sequentially receive three doses of PUR118 (5.5 mg, n = 18; 11.0 mg, n = 18; 2.8 mg, n = 16). Each dose was inhaled 3 times (1, 13, 25 h, preceded by 2 puffs salbutamol) before the ozone exposure (250 ppb, 3 h intermittent exercise). Sputum was induced 3 h after the end of exposure.

RESULTS:

Sputum neutrophils, sputum CD14+ cells, as well as concentrations of IL1B, IL6, IL8, MMP9, and TNFA in sputum supernatant significantly increased after ozone exposure (n = 24). The percentage of sputum neutrophils (n = 12 who completed all treatments) did not change following treatment with different doses of PUR118. The high dose treatment group (n = 16) showed a decrease in the percentage and number of sputum macrophages (p ≤ 0.05) as well as a decrease in blood neutrophils (p = 0.04), and an increase in blood CD14 + cells (p = 0.04) compared to baseline. All dosages of PUR118 were safe and well tolerated.

CONCLUSION:

Ozone challenge resulted in the expected and significant increase of sputum inflammatory parameters. Treatment with multiple rising doses of PUR118 was safe and three applications within 25 h prior to the ozone challenge had small effects on ozone-induced airway inflammation.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01690949. Registered 12 September 2012.

项与 Pulmatrix, Inc. 相关的新闻（医药）

2024-11-14

·药研网

睿跃生物与Pulmatrix达成合并协议！

临床阶段生物制药公司Pulmatrix宣布与Cullgen（睿跃生物）达成合并协议。此次拟合并旨在创建一家纳斯达克上市的公司。根据合并协议的条款和条件，在合并结束时，合并前Pulmatrix股东预计将持有合并公司约3.6%的股份，合并前睿跃生物股东预计将拥有合并公司约96.4%的股份，该公司将以睿跃生物的名义运营，总部位于加利福尼亚州圣地亚哥，在纳斯达克资本市场交易。Pulmatrix股东还将获得特别现金股息，前提是Pulmatrix在收盘时的净现金超过250万美元，但须进行某些调整。该交易预计将于2025年3月底完成，但须获得股东和中国证监会的批准。 Cullgen目前拥有三个降解剂项目正在或即将启动I期临床试验。CG001419是一种首创的、选择性的、临床活性的口服泛TRK降解剂，正在两项独立的临床试验中进行研究——一项针对实体瘤，另一项用于治疗急性和慢性疼痛。在癌症试验中，Cullgen已经为十名患者给药，至今未观察到剂量限制性毒性、治疗相关严重不良事件或≥3级治疗相关不良事件。在疼痛试验中，Cullgen最近获得了澳大利亚人类研究伦理委员会（HREC）的批准，开始招募患者以评估CG001419在健康志愿者中的安全性和药代动力学特征。Cullgen预计将在2025年初招募首位患者。该项目旨在提供一种新型的非阿片类、非甾体抗炎药（NSAID）镇痛药，以填补疼痛治疗领域未满足的医疗需求。睿跃生物是一家私营临床阶段生物药物公司，应用其专有的靶向蛋白降解uSMITE™平台来发现和推进治疗癌症和其他疾病的疗法.合并后的公司预计在接近尾声时将拥有约6500万美元的现金和现金等价物，以通过多个临床里程碑和2026年的预期跑道提供资金。 2018年，睿跃生物由熊跃、金坚、罗楹三人联合发起成立。熊跃是北卡罗来纳大学教堂山分校化学与生物物理学系的教授，金坚是美国西奈山医学院化学生物学及药物开发中心主任，罗楹则是在中美两地拥有三十年生物科技产业经验的资深人士。 2019年，睿跃生物完成了由红杉中国参与领投的1600万美元A轮融资。 2021年2月，睿跃生物宣布成功完成5000万美元B轮融资。多家著名国际风险投资机构参与了本轮融资，新投资者有本草资本，Heights Capital、Octagon Capital、和玉资本和中南创投。现有投资者GNI集团，红杉资本和弘晖资本，也参加了本轮融资。 2023年5月，睿跃生物完成了由阿斯利康中金领投，日本GNI集团，信熹资本，锡创投和沃杰资本等机构支持的3500万美元C轮融资。 2023年6月，安斯泰来宣布与睿跃生物达成了一笔总金额高达19亿美元的研究合作和独家选择协议。用于合作开发潜在first-in-class蛋白降解剂。内容来源于网络，如有侵权，请联系删除。

临床1期

2024-11-14

·氨基观察

礼来替尔泊肽可以预防糖尿病；睿跃生物借壳上市

氨基观察-创新药组原创出品作者 | 黄凯 GLP-1是万能的！ 11月13日，礼来公布SURMOUNT-1研究的3年随访详细结果。数据显示，对于肥胖且合并糖尿病前期的受试者，经替尔泊肽治疗176周，体重最高可减轻约20%，而且进展至2型糖尿病的风险显著降低93%。 Biotech自救进行时。 11月13日，睿跃生物与纳斯达克上市公司Pulmatrix达成合并协议，旨在创建一家美股Biotech，专注于靶向蛋白降解新药开发。基因疗法新里程碑。 11月13日，PTC Therapeutics宣布，美国FDA加速批准基因疗法Kebilidi用于治疗芳香族L-氨基酸脱羧酶缺乏症的儿童和成人患者，无论他们的疾病严重程度为何。这是FDA批准的首个直接注射到大脑的基因疗法。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）普米斯9.5亿美元卖身BioNTech 11月13日，普米斯宣布，BioNTech将以8亿美元预付款收购普米斯100%已发行股本。此外，BioNTech将在普米斯达到双方约定的里程碑条件时，额外支付最高 1.5 亿美元的里程碑付款。 2）百洋医药签订市场推广服务协议 11月14日，百洋医药公告，近日，公司全资子公司北京华昊中天签订了《市场推广服务协议》，约定北京华昊中天指定百洋智合在区域内进行指定产品（优替德隆注射液）的独家市场推广服务。 3）葛兰素史克任命中国区事业部负责人日前，葛兰素史克中国向员工发布一则人事任命通告，宣布傅祁越将于当日起加入GSK 中国特药事业部担任副总裁、抗感染负责人，常驻上海，直接汇报于 GSK 中国特药业务负责人张宁。 / 02 / 资本信息 1）与Pulmatrix合并，睿跃生物借壳上市 11月13日，睿跃生物与纳斯达克上市公司Pulmatrix达成合并协议，旨在创建一家美股Biotech，专注于靶向蛋白降解新药开发。 2）派格生物向港交所递交上市申请 11月13日，据港交所披露易，派格生物递交上市申请。 / 03 / 医药动态 1）万明赛伯G01滴眼液获临床许可 11月14日，据CDE官网，万明赛伯G01滴眼液获临床许可，拟开展治疗青光眼导致的视神经损伤的研究。 2）贝来药业人脐带间充质干细胞注射液获临床许可 11月14日，据CDE官网，贝来药业人脐带间充质干细胞注射液获临床许可，拟开展治疗慢加急性肝衰竭的研究。 3）科兴中维冻干人用狂犬病疫苗（Vero细胞）获临床许可 11月14日，据CDE官网，科兴中维冻干人用狂犬病疫苗（Vero细胞）获临床许可，拟用于狂犬病预防。 4）新樾生物ND-003片获临床许可 11月14日，据CDE官网，新樾生物ND-003片获临床许可，拟开展治疗胃肠道间质瘤的研究。 5）中国生物制药四代EGFR抑制剂获美国临床试验许可 11月14日，中国生物制药发布公告表示，四代EGFR抑制剂TQB3002获美国临床试验许可，即将启动1期临床。 / 04 / 器械跟踪 1）奥林巴斯为苏州新工厂投产做准备 11月14日，奥林巴斯正为苏州新工厂投产做准备，将开始在当地组装在华销售的内窥镜等主力产品。奥林巴斯执行董事、中国业务负责人土屋英尚透露，核心部件将从日本生产后送至苏州的新工厂进行组装。 2）南微医学一次性使用乳头括约肌切开刀获注册许可 11月14日，据NMPA官网，南微医学一次性使用乳头括约肌切开刀获注册许可。 3）海杰亚微波消融仪获注册许可 11月14日，据NMPA官网，海杰亚微波消融仪获注册许可。 4）美敦力脊柱外科手术导航定位系统获注册许可 11月14日，据NMPA官网，美敦力脊柱外科手术导航定位系统获注册许可。 5）半岛医疗皮秒Nd:YAG激光治疗仪获注册许可 11月14日，据NMPA官网，半岛医疗皮秒Nd:YAG激光治疗仪获注册许可。 6）硅基传感持续葡萄糖监测系统获注册许可 11月14日，据NMPA官网，硅基传感持续葡萄糖监测系统获注册许可。 / 05 / 海外药闻 1）礼来替尔泊肽可以预防糖尿病 11月13日，礼来公布SURMOUNT-1研究的3年随访详细结果。数据显示，对于肥胖且合并糖尿病前期的受试者，经替尔泊肽治疗176周，体重最高可减轻约20%，而且进展至2型糖尿病的风险显著降低93%。 20）FDA批准直接注入大脑的基因疗法 11月13日，PTC Therapeutics宣布，美国FDA加速批准基因疗法Kebilidi用于治疗芳香族L-氨基酸脱羧酶缺乏症（AADCD）的儿童和成人患者，无论他们的疾病严重程度为何。这是FDA批准的首个直接注射到大脑的基因疗法。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

高管变更基因疗法引进/卖出疫苗

2024-11-14

·Endpoints

Zai Lab aims to raise $200M; Kronos Bio to seek ‘strategic’ options

Plus, news about Allogene, Telix, Cullgen, Pulmatrix, Gilead, Innocoll, Durect and Sensei: Zai Lab’s $200M offering: The Shanghai-based drugmaker is selling shares the same week as announcing revenue growth of 47% year-over-year. It also said it plans to submit the schizophrenia drug KarXT for approval in China “early” next year. The FDA in September approved the medicine, owned by Bristol Myers Squibb. — Kyle LaHucik Kronos Bio to seek “strategic alternatives”: The company made the decision after looking at the data for a CDK9 inhibitor called istisociclib and deeming “the benefit-risk profile” as not warranting additional development. Istisociclib was designed to treat platinum-resistant high-grade serous ovarian cancer. Kronos had $124.9 million in cash, cash equivalents and investments as of the end of September. — Max Gelman Allogene halts enrollment in Phase 1 leukemia trial: The company was investigating cemacabtagene in patients with relapsed or refractory chronic lymphocytic leukemia. In its latest securities filing, Allogene blamed slow enrollment and “the emergence of new alternative treatment options” for its decision to halt enrollment altogether. The company added that it would be reallocating resources from the trial to other programs. Its shares $ALLO were down about 6% on Thursday morning. — Katherine Lewin Telix’s Nasdaq debut : The Australian radiopharma started trading on the Nasdaq as $TLX on Thursday. The company didn’t sell any new shares as part of the listing, though. It had pulled its Nasdaq IPO plans in the 11th hour in June. — Kyle LaHucik Cullgen to take Pulmatrix’s spot: Cullgen and the Nasdaq-listed Pulmatrix will reverse merge in a deal expected to close by the end of March. Cullgen makes protein degraders and degrader-antibody conjugates, or DACs, that are in Phase 1. Another DAC maker, Orum Therapeutics, is looking to go public , but in South Korea. Pre-merger Cullgen stockholders will get about 96.4% of the combined company. — Kyle LaHucik Gilead lays off 72 workers in Seattle: The cuts were attributed to a site closure and are set to begin in January, according to a WARN notice in Washington state. A spokesperson for Gilead did not immediately respond to a request for comment. The pharma gained a foothold in the Seattle area after acquiring Corus Pharma for $365 million in 2006. — Max Bayer Innocoll Pharmaceuticals ends licensing pact with Durect: Durect said the termination is effective in May. Innocoll had snagged US commercial rights to Durect’s non-opioid analgesic in December 2021. — Max Bayer Sensei to lay off 46% of staff, close research site in Rockville, MD: The cuts will extend Sensei’s runway into 2026, the company said. They will also help Sensei “focus resources on advancing the clinical development of SNS-101,” which the company is developing both as a monotherapy and a combination in advanced solid tumors. It had 27 employees as of Feb. 23. Its stock $SNSE fell about 11% on Thursday morning. — Max Gelman

临床1期上市批准引进/卖出并购

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药物(靶点)	适应症	全球最高研发状态

PUR-1800 ( SRC x Syk x p38α )	慢性阻塞性肺疾病更多	临床2期
Pulmazole	变应性支气管肺曲霉菌病更多	临床2期
PUR-4000	呼吸障碍更多	临床前
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CM-YJH01 ( GLRX )	特发性肺纤维化更多	药物发现