A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

开始日期2021-01-12

申办/合作机构

Synairgen Research Ltd.

NCT04518410 / Completed临床2/3期IIT

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

开始日期2020-08-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

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项与干扰素β-1a(The University of Southampton) 相关的文献（医药）

2024-05-01·Journal of Neurology

Correction to: The impact of metformin use on the outcomes of relapse‑remitting multiple sclerosis patients receiving interferon beta 1a: an exploratory prospective phase II open‑label randomized controlled trial

作者: Abdelgaied, Mohamed Y ; Rashad, Mohamed Hamed ; El-Tayebi, Hend M ; Solayman, Mohamed H

Multiple sclerosis (MS) is a chronic demyelinating neurodegenerative disorder.Elevated levels of pro-inflammatory mediators and some oxidative stress parameters can accelerate the demyelination process.We aimed to investigate the efficacy and safety of metformin as an adjuvant therapy to interferon beta 1a (IFNβ-1a) in relapsing-remitting multiple sclerosis (RRMS) patients.Eighty RRMS patients were equally divided into 2 groups: the intervention group receiving IFNβ-1a plus 2 gm of metformin once daily and the control group receiving IFNβ-1a alone.Interleukin 17 (IL17), interleukin 22 (IL22), malondialdehyde (MDA), T2 lesions in magnetic resonance imaging (MRI) and expanded disability status scale (EDSS) were assessed at the baseline and then after 6 mo.At baseline, there were no statistically significant differences between the two groups (p > 0.05).After 6 mo, the change in the median (interquartile range) of the results for both the intervention and control group were; IL17 (- 1.39 (4.19) vs - 0.93 (5.48), p = 0.48), IL22 (- 0.14 (0.48) vs - 0.09 (0.6), p = 0.53), and EDSS (0 vs 0, p = 1), resp.The mean (standard deviation) change in MDA for the intervention and control group was - 0.93 (2.2) vs - 0.5 (2.53), p = 0.038, resp.For MRI results, 21 patients had stationary and regressive course and 1 patient had a progressive course in the intervention arm vs 12 patients had stationary and regressive course and 4 had a progressive course in the control arm, p = 0.14.Adding metformin to IFNβ-1a demonstrated a potential effect on an oxidative stress marker (MDA).However, there is no statistically significant effect on immunol., MRI and clin. outcomes.We recommend larger scale studies to confirm or negate these findings.

2024-03-01·Journal of Neurology

The impact of metformin use on the outcomes of relapse-remitting multiple sclerosis patients receiving interferon beta 1a: an exploratory prospective phase II open-label randomized controlled trial

Article

作者: Rashad, Mohamed Hamed ; Abdelgaied, Mohamed Y ; El-Tayebi, Hend M ; Solayman, Mohamed H

BACKGROUNDMultiple sclerosis (MS) is a chronic demyelinating neurodegenerative disorder. Elevated levels of pro-inflammatory mediators and some oxidative stress parameters can accelerate the demyelination process. We aimed to investigate the efficacy and safety of metformin as an adjuvant therapy to interferon beta 1a (IFNβ-1a) in relapsing-remitting multiple sclerosis (RRMS) patients.METHODEighty RRMS patients were equally divided into 2 groups: the intervention group receiving IFNβ-1a plus 2 gm of metformin once daily and the control group receiving IFNβ-1a alone. Interleukin 17 (IL17), interleukin 22 (IL22), malondialdehyde (MDA), T2 lesions in magnetic resonance imaging (MRI) and expanded disability status scale (EDSS) were assessed at the baseline and then after 6 months.RESULTSAt baseline, there were no statistically significant differences between the two groups (p > 0.05). After 6 months, the change in the median (interquartile range) of the results for both the intervention and control group were; IL17 (- 1.39 (4.19) vs - 0.93 (5.48), p = 0.48), IL22 (- 0.14 (0.48) vs - 0.09 (0.6), p = 0.53), and EDSS (0 vs 0, p = 1), respectively. The mean (standard deviation) change in MDA for the intervention and control group was - 0.93 (2.2) vs - 0.5 (2.53), p = 0.038, respectively. For MRI results, 21 patients had stationary and regressive course and 1 patient had a progressive course in the intervention arm vs 12 patients had stationary and regressive course and 4 had a progressive course in the control arm, p = 0.14.CONCLUSIONAdding metformin to IFNβ-1a demonstrated a potential effect on an oxidative stress marker (MDA). However, there is no statistically significant effect on immunological, MRI and clinical outcomes. We recommend larger scale studies to confirm or negate these findings.TRIAL REGISTRATIONClinicalTrials.gov number: NCT05298670, 28/3/2022.

2024-02-17·Prehospital Emergency Care

Emergency Medical Services Management of Bronchospasm in the United States: A Cross-Sectional Analysis and Nationwide Quality Assessment

Article

作者: Peters, Gregory A ; Camargo, Carlos A ; Ordoobadi, Alexander J ; Goldberg, Scott A ; Cash, Rebecca E ; Kolb, Lily M

Background/Objective: Bronchospasm, caused by asthma and other related conditions, is a significant cause of morbidity and mortality commonly managed by emergency medical services (EMS). We aimed to evaluate the quality of prehospital management of bronchospasm by EMS in the US.Methods: The National EMS Information System Public Release Research dataset, a nationwide convenience sample of prehospital patient care report data from 2018 to 2019, was used to capture 9-1-1 activations where patients aged ≥2 years were treated and transported by EMS for suspected bronchospasm. First, we described the extent to which EMS care met eight quality measures identified from available statewide EMS protocols, existing quality measures, and national guidelines. Second, we quantified the extent of risk-standardized agency-level variation in administration of inhaled beta agonists and systemic corticosteroids using logistic regression models, accounting for patient characteristics, severity, and clustering by agencies. Third, we compared rates of completed prehospital interventions between pediatric (age <18 years) versus adult patients using two-sample t-tests.Results: A total of 1,336,988 EMS encounters for suspected bronchospasm met inclusion criteria. Median age of patients was 66 years, with only 4% pediatric; 55% were female. Advanced life support (ALS) units managed 94% of suspected bronchospasm. Respiratory rate (98%) and pulse oximetry (96%) were documented in nearly all cases. Supplemental oxygen was administered to hypoxic patients by 65% of basic life support (BLS) and 73% of ALS units. BLS administered inhaled beta-agonist therapy less than half the time (48%), compared to 77% by ALS. ALS administered inhaled anticholinergic therapy in 38% of cases, and systemic corticosteroids in 19% of cases. Pediatric patients were significantly less likely to receive supplemental oxygen when hypoxic, inhaled beta-agonists, inhaled anticholinergics, or systemic corticosteroids.Conclusions: We found important gaps in recent EMS practice for prehospital care of suspected bronchospasm. We highlight three targets for improvement: inhaled beta-agonist administration by BLS, systemic corticosteroid administration by ALS, and increased interventions for pediatric patients. These findings indicate important areas for research, protocol modification, and quality improvement efforts to improve EMS management of bronchospasm.

项与干扰素β-1a(The University of Southampton) 相关的新闻（医药）

2024-09-28

·同写意

渤健求变，挺进自免

本届大会以“共建创新生态共赢产业未来”为主题，聚焦生物医药出海与国际化创新、创新药投融资、医疗器械等产业发展风向标，打造“高端化、国际化、专业化、立体化”的年度盛会。二十多年后，渤健和优时比终于在相伴而行的治疗红斑狼疮（SLE）路上收到了好消息。 9月24日，两家公司宣布在研药物dapirolizumab pegol联合疗法治疗SLE的III期试验达到主要终点。数据显示，这款产品能够显著改善中度至重度SLE患者的疾病活动程度。渤健发言人表示，“根据全球监管标准”，需要进行第二次III期试验来确认该药物的安全性和有效性。优时比和渤健预计在今年启动该疗法的第二项III期试验PHOENYCS FLY。系统性红斑狼疮是一种慢性、使人衰弱的自身免疫性疾病，影响多个器官系统，对女性的影响尤为严重。SLE患者的死亡风险较高，常见死因包括感染和心血管疾病。据估计，美国有超过20万人患有SLE，但只有少数药物可用，包括皮质类固醇等“旧版本”的药物，以及GSK的Benlysta、阿斯利康的Saphnelo等较新的靶向疗法。 Dapirolizumab pegol如若得到批准，除了给这款自免疾病带来新的治疗方案之外，渤健也将在自己的多元化布局上再下一城。长久以来，一些投资者认为渤健过度依赖高风险的神经科学项目，如今渤健也试图实现多样化，证明自己也可以成为免疫研究的主要参与者。 1 免疫学扩张渤健将红斑狼疮作为其免疫学扩张的起点，是个不错的选择。自2003年以来，渤健一直在与优时比合作研究dapirolizumab pegol。但也很显然，这并不是一个好下手的适应症。 2018年，在一项针对SLE患者的小型研究中，dapirolizumab pegol的表现未能优于安慰剂。渤健和优时比得出的结论是，该研究的设计部分有问题。两家公司进一步测试了该药物，在另一项试验中招募了病情较重的患者，并更好地控制了类固醇的使用。此次公布数据的III期试验中，dapirolizumab pegol联合SOC达到了主要终点，即在第48周，与安慰剂联合SOC相比，患者的中度至重度疾病活动度的改善更为显著。在衡量疾病活动度和发作的关键次要终点中，亦观察到患者在临床上有所改善。 Dapirolizumab pegol的安全性与之前的研究结果基本上一致，也与接受免疫调节剂治疗的SLE研究受试者的预期安全性结果一致，耐受性良好，严重治疗出现不良事件的发生率很低，与安慰剂组相似。该药物的具体数据尚未披露，不过，外面的世界并没有给时间让其慢慢成长，竞争正在升温。至少有十几家公司正在评估已经处于或即将进入人体试验的细胞疗法和新型抗体药物，治疗红斑狼疮。去年12月，在一次医学会议上公布的一项德国研究显示，在15名患有狼疮或其他两种自身免疫性疾病之一且先前治疗无效的患者中，接受细胞治疗后所有患者均缓解，一些应答持续了两年。与此同时，许多开发人员正转向以红斑狼疮为起点的免疫疾病研究。今年4月，曾为治疗癌症而生的Cullinan Oncology，也宣布开始寻求红斑狼疮等免疫疾病的细胞疗法，并更名为Cullinan Therapeutics。渤健还有别的牌——另一种实验药物litifilimab（BIIB059）。作为目前进展最快的一款BDCA2靶向药，litifilimab用于SLE和皮肤型红斑狼疮（CLE）的的临床试验均已进入III期阶段。今年春天，渤健还花费高达12亿美元的资金收购了HI-Bio，这是一家年轻的生物技术公司，主要开发自免适应症。渤健免疫学开发部门负责人Diana Gallagher在接受采访时说道，在红斑狼疮中，“我们处于非常稳固的地位”。自2022年底任命Chris Viehbacher为渤健首席执行官以来，该公司更加专注于将红斑狼疮作为锚点，扩大免疫疗法的范围。 2 发展的十字路口作为最早专注于精神和神经退行性疾病的公司，渤健毫无疑问是神经学领域的头部选手。但随着两款阿尔茨海默病药物并不算出色的表现，渤健确实处在比较尴尬的境地。Aduhelm已然被放弃，另一款Aβ抗体药Lecanemab商业化也不及最初的预期。根据渤健合作方卫材的财报，Lecanemab在2024上半年共计收入91亿日元（约0.60亿美元），预计2024财年的全球收入将达到565亿日元（约3.7亿美元）。而在此前，卫材曾乐观预测Lecanemab在2026财年，全球销售额可以达到2900亿日元（近20亿美元）。不过，渤健仍在推进阿尔茨海默病的研发，预计到2026年底，其另一款靶向tau蛋白的ASO药物BIIB080可能会获得Ⅱ期结果。在另一个其拥有领导者地位的适应症——多发性硬化（MS）领域，渤健的产品也有些后继乏力。从1996年FDA批准干扰素β-1a（Avonex）以来，渤健在MS领域就开始发光发热，Avonex一度为渤健带来了超30亿美元的年销售额。 MS治疗药物主要包括干扰素及其升级产品、小分子以及单抗，所有这些渤健都有涉猎，研发进度和产出收益甚至全球领先。第4款MS口服药物Tecfidera的面世，更是凭着可将复发频率降低超50%，残疾进程缩短近40%的效果，在2019年斩获近45亿美元。据医药魔方统计，近十年以来，MS药物在渤健收入最高峰时占比达到82.51%。然而，谁都无法躲过专利到期，仿制药以及同领域产品的激烈围剿。财报显示，今年第二季度，渤健MS治疗药物的营收为11.50亿美元，虽然仍贡献了渤健近半的营收，但与去年同期相比下滑5%。最近，关于MS药物，渤健又受到了贿赂的指控。美国巴尔的摩市近日对渤健提起诉讼，指控其通过不正当手段，利用贿赂手段影响药房福利管理公司（PBM）的处方药目录，偏袒其高价MS药物Tecfidera，抵制仿制药的竞争。据起诉书内容，渤健支付了巨额费用，要求PBM“操纵”Tecfidera仿制药在其目录中的位置，从而保护其市场地位和利润。贿赂行为涉及多家大型PBM，包括CVS Health、UnitedHealth、Cigna等。渤健对此进行了否认，称其与PBM的关系合法透明，“我们否认所有关于不当行为的指控，并将积极捍卫我们的权利”。渤健营收的另一个重要组成部分是生物类似药。2024年第二季度，其生物仿制药营收为1.98亿美元，同比增加2%。但在两年前，渤健向三星集团出售合资公司股份的举动，让业界猜测这家MNC也想要剥离生物类似药业务。 2024年第二季度，渤健总营收24.65亿美元，同比持平；2024上半年，渤健总营收47.55亿美元，同比下滑3%。站在发展的十字路口，对于上任还不算久的Chris Viehbacher来说，往哪个方向都不是容易做出的选择。参考文献： 1、Biogen, UCB get the lupus data they’ve waited two decades for；biopharmadive 2、Baltimore claims Biogen ‘bribed’ PBMs to favor its pricey MS drug over generics；STAT 同写意媒体矩阵，欢迎关注↓↓↓

临床3期临床失败免疫疗法临床终止寡核苷酸

2024-02-18

·药精通Bio

【行研】盘点2023年值得关注的创新小分子药

IDC2024第六届化学创新药与改良型新药研发论坛议程发布（点击图片查看）：合作展位事宜请联系：李欣欣 158 0045 2389（报名即将截止，扫码报名）文章来源：凯莱英Asymchem近年来，小分子药物凭借诸多天然优势——分子量小、可以穿透细胞膜、更易口服等特点，深受全球医药研发企业追捧，重磅创新药不断问世，成绩斐然、有目共睹。从2023年FDA及NMPA获批的小分子新药数量来看，分别占比55%与73%，足以表明小分子药物占据重要的研发地位。小分子化药与大分子药物特点对比如下：表1.小分子化药与大分子生物药对比来源：奇点网从全球-创新药领域投融资细分赛道上看，前五大热门赛道为小分子药物、大分子药物、药物递送、细胞疗法和人工智能。从占比上明显看出，小分子药物在全球创新药研发中依然占据重要地位。图1.海内外创新药投资细分赛道来源：医药魔方近5年来，FDA获批的小分子新药数量占比上可窥见一斑。2023年FDA旗下的CDER共批准55款新药，其中小分子药物达到55%，占据半壁江山，该数据在2019年、2020年、2021年、2022年分别为65%、62%、56%、46%，整体趋势呈现V字形，侧面反映了小分子药历经低谷、逆境重生的发展历程。图2.2019-2023年FDA获批的各类新药数量占比来源：公开资料整理复盘国内2023年新药审批上市情况，2023年共有超过80款新药在中国首次获批，其中1类新药有32款（不含诊断类药物和疫苗），创下近年来新高，生物制品3.1类新药约10款，化药5.1类新药约40款。从获批药物的分子类型来看，小分子药物仍然是“主力军”，占比高达73%，它们的靶点涵盖了CDK4/6、S1P、MET、BTK、DPP-4、ALK、ROCK2、JAK3/TEC、c-MET等。其中，有多款药物为相应患者带来了全新的治疗选择，例如：武田（Takeda）酪氨酸激酶抑制剂莫博赛替尼胶囊，为一款专门为携带EGFR外显子20插入突变的非小细胞肺癌（NSCLC）患者设计的口服疗法；阿斯利康和默沙东合作开发的MET抑制剂司美替尼胶囊，为中国首个获批的I型神经纤维瘤病（NF1）治疗药物；辉瑞的JAK3/TEC抑制剂利特昔替尼胶囊，是一款用于12岁+重度斑秃青少年的口服药物。除小分子药物之外，在中国首次获批的新药还包括其它的分子类型，其中不乏CAR-T细胞产品、小干扰RNA（siRNA）、单抗、双抗、ADC等，上市药品覆盖了PD-L1、CD19、CD20、IL-23、PCSK9、HER2、RANKL、IL-1、FcRn、Ang-2/VEGF-A等诸多靶点。图3.2023年首次在中国获批的新药分子类型分布来源：医药观澜整理2023年中国获批的小分子新药，其中不乏值得重点关注的几款，被认定为首创性疗法或突破性疗法：琥珀酸莫博赛替尼——适用于治疗含铂化疗期间或之后进展且携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌成人患者。该药是全球首款也是目前唯一获批的治疗EGFR 20号外显子插入突变晚期非小细胞肺癌的口服靶向药物，其获批标志着小细胞肺癌治疗史上迎来二十年来的重大突破，也表明该病在中国正式进入靶向治疗新时代。莫博赛替尼的成功是结构的创新，传统药物与EGFR 20号外显子插入突变体结合存在空间位阻，而莫博赛替尼创新设计成具有异丙酯结构的柔性单环核心，能更有效地与EGFR 20号外显子插入突变有效结合，具有精准选择和亲和力更高的优势，从而攻克临床难题。盐酸奥扎莫德胶囊——用于治疗成人复发型多发性硬化，该病于2018年被纳入我国《第一批罕见病目录》。多发性硬化是一种以中枢神经系统炎性脱髓鞘病变为主要特点的免疫介导性疾病，临床表现为运动障碍、认知功能障碍等。该药作为一种全新分子结构的高选择性S1P1和S1P5受体调节剂，可适度抑制淋巴细胞迁出，并直接作用于中枢进行抗炎和神经保护。两项大型阳性药物对照III期研究证实，与干扰素β-1a相比，其在显著降低疾病复发和MRI病灶数的同时，还能有效减少患者脑容量丢失，改善患者认知功能，实现“躯体+认知”双重保护。其也成为全球首个在大型III期临床研究中“全面评估脑容量丢失”的多发性硬化疾病修正治疗（DMT）药物。目前，盐酸奥扎莫德胶囊已纳入新版医保目录，新版目录于2024年1月1日起实行。硫酸氢司美替尼胶囊——该药作为神经纤维瘤病领域首个创新药物，主要治疗3岁及3岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的I型神经纤维瘤病（NF1）儿童患者。神经纤维瘤病（NF）是一种罕见的、进行性的遗传性疾病，在其三种主要分型中NF1约占98%。司美替尼可阻断参与促进细胞生长的特定酶（MEK1和MEK2），在NF1中，这些酶过度活跃，导致丛状神经纤维瘤以不受控制的方式生长。司美替尼通过阻断特定酶可减缓病情。司美替尼也是中国首个获批的NF1领域治疗药物。甲磺酸贝舒地尔片——赛诺菲研发的甲磺酸贝舒地尔片是首个且唯一中国获批治疗cGVHD的靶向药物，用于治疗对糖皮质激素或其他系统治疗应答不充分的12岁及以上慢性移植物抗宿主病（cGVHD）患者。30%~70%的患者经造血干细胞移植后会出现cGVHD。临床数据显示，甲磺酸贝舒地尔片治疗整体缓解率（ORR）可达75%，6个月无失败生存率（FFS）可达75%，2年总体生存率可达89%，能够显著降低激素用量，甚至停用激素，并能明显改善肺部cGVHD症状，作为二线治疗cGVHD的适应症获批，该药填补了此治疗领域的空白。甲苯磺酸利特昔替尼胶囊——辉瑞的甲苯磺酸利特昔替尼为重度斑秃患者提供了全新的治疗选择，同时，这也是全球首款针对患有严重斑秃的青少年的治疗方法。药融云数据显示，截至目前，全球只有两种JAK抑制剂获批用于治疗斑秃，即巴瑞替尼和利特昔替尼。利特昔替尼是JAK3/TEC激酶家族双通道抑制剂，每日仅需口服一次，通过阻断ATP结合位点，不可逆地抑制JAK3和TEC激酶家族。从作用机制来看，利特昔替尼可阻断信号分子和免疫细胞活性，与第一代泛JAK抑制剂相比，在降低毒性方面更有优势，曾被国药监局认定为突破性疗法。表2.2023年中国获批的小分子新药来源：国盛证券除了已获批上市的小分子新药， 2023年license out的国产小分子药都值得关注，比如和黄医药的呋喹替尼,以首付款4亿美元出让给武田制药；诚益生物的ECC5004，以首付款1.85 亿美元售让给阿斯利康；英矽智能的ism3091，以0.8亿美元首付款出售给Exelixis；赞荣医药的ZN-A-1041，以0.7亿美元首付款出售给罗氏，以及和誉医药将Pimicotinib以0.7亿美元授权给Merck KGaA等。显而易见，全球小分子创新药近两年有升温回暖趋势，而我国药监局对创新品种的开放并包、积极鼓励发展的态度始终未变，相信在全球药企的共同努力下，小分子创新药将继续蓬勃发展，迎来更广阔的明天。References参考文献1、20231224-国盛证券-医药生物行业周报：国内&海外创新药2023年发生了什么？2024年有哪些亮点？2、20231203-国联证券-医药生物行业周专题：为何出海成为近期焦点？3、20231215-东海证券-2024年度投资策略报告会_医药生物行业年度策略：多重筑底，向阳而生ENDIDC2024第六届化学创新药与改良型新药研发论坛议程发布（点击图片查看）：合作展位事宜请联系：李欣欣 158 0045 2389

细胞疗法免疫疗法上市批准疫苗抗体药物偶联物

2023-07-15

·PRNewswire

Chronic Obstructive Pulmonary Disease Pipeline Research 2023: Focus on 65+ Companies and 70+ Pipeline Drugs

DUBLIN, July 14, 2023 /PRNewswire/ -- The "Chronic Obstructive Pulmonary Disease - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. With an extensive focus on 65+ companies and 70+ pipeline drugs, this report provides a detailed analysis of the current scenario and growth prospects across the indication. The report encompasses a comprehensive overview of the pipeline drug profiles, covering both clinical and nonclinical stage products. Additionally, it includes a thorough assessment of therapeutics, considering product type, stage, route of administration, and molecule type. Inactive pipeline products in this space are also highlighted, providing a holistic view of the COPD pipeline landscape. To provide a comprehensive understanding, this report outlines the present scenario and growth prospects in the COPD field. It offers detailed insights into the disease overview and treatment guidelines for Chronic Obstructive Pulmonary Disease, setting the stage for a deeper exploration of the pipeline landscape. Furthermore, the report delves into the commercial assessment and clinical assessment of the pipeline products under development. It provides detailed descriptions of each drug, including their mechanisms of action, clinical studies, NDA approvals (if any), and comprehensive product development activities. This encompasses technology, COPD collaborations, licensing, mergers and acquisitions, funding, designations, and other relevant product-related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Obstructive Pulmonary Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease Emerging Drugs Chapters This segment of the Chronic Obstructive Pulmonary Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Chronic Obstructive Pulmonary Disease Emerging Drugs Benralizumab: AstraZeneca Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin-5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Dupilumab: Sanofi Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL) that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reactions, and rhinosinusitis. Dupilumab was generated by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Dupilumab is under investigation for its potential therapeutic use in chronic obstructive pulmonary disease and is currently in the Phase III stage of development. Tezepelumab: Amgen Tezepelumab (Tezspire) is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses, and other airborne particles. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. Tezspire is being developed in collaboration with AstraZeneca and is currently being evaluated in Phase II to treat patients with chronic obstructive pulmonary disease. SNG001: Synairgen SNG001 boosts antiviral responses in the lungs, has a beneficial effect on lung function, and in more difficult to treat patients, improves asthma control during cold infections. The drug is currently being evaluated in the Phase II stage of development to treat patients with COPD. GSK3923868: GlaxoSmithKline GSK3923868, is a PI4kb inhibitor in development as a treatment for viral COPD exacerbations. It belongs to the class of antiasthmatics. The drug acts as a 1-phosphatidylinositol-4-kinase inhibitor. Currently, the drug is in Phase I of its clinical trial evaluation for the treatment of chronic obstructive pulmonary disease. Chronic Obstructive Pulmonary Disease: Therapeutic Assessment This segment of the report provides insights about the different Chronic Obstructive Pulmonary Disease drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Chronic Obstructive Pulmonary Disease There are approx. 65+ key companies which are developing the therapies for Chronic Obstructive Pulmonary Disease. The companies which have their Chronic Obstructive Pulmonary Disease drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Intramuscular Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Product Type Chronic Obstructive Pulmonary Disease Report Insights Chronic Obstructive Pulmonary Disease Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Key Players Sanofi AstraZeneca Amgen Synairgen GlaxoSmithKline Eisai Meridigen Biotech Chiesi EmeraMed Limited Verona Pharma Tetherex Pharmaceuticals Mereo BioPharma Key Products Lemborexant UMC119-06 CHF5259 Emeramide Ensifentrine SNG001 GSK3923868 Benralizumab Dupilumab Tezepelumab SelK2 BCT197 For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

临床2期临床3期免疫疗法临床1期

100 项与干扰素β-1a(The University of Southampton) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	干扰素β-1a(The University of Southampton)	L03AB07	DB00060

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
新型冠状病毒感染	药物发现	比利时	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	墨西哥	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	法国	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	巴西	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	罗马尼亚	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	塞尔维亚	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	意大利	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	德国	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	英国	Synairgen Research Ltd.	2021-01-12
新型冠状病毒感染	药物发现	阿根廷	Synairgen Research Ltd.	2021-01-12

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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


NCT04518410 (ACTIV-2/A5401, Pubmed \| EClinicalMedicine)	临床2期	新型冠状病毒感染	-	Inhaled interferon-β1a (SNG001)	夢襯壓範獵壓糧願鏇範(衊蓋築蓋簾築願製遞鹹) = 膚壓選醖夢壓構憲製獵膚衊壓願鏇鏇壓鹽顧觸 (膚鬱蓋繭膚壓構鹽衊鏇 )	积极	2023-11-01
				Blinded pooled placebo	夢襯壓範獵壓糧願鏇範(衊蓋築蓋簾築願製遞鹹) = 顧憲蓋願獵構積願衊願膚衊壓願鏇鏇壓鹽顧觸 (膚鬱蓋繭膚壓構鹽衊鏇 )
NCT04732949 (SPRINTER, CTgov)	临床3期	新型冠状病毒感染	623	SNG001 (SNG001)	(膚鹽鹽衊顧膚襯願築鬱) = 選顧夢鏇鹽窪淵憲醖選淵築遞艱構鹹顧築衊廠 (鹹積鏇構獵蓋築製蓋製, 憲醖遞鏇衊窪鑰艱積鹹 ~ 簾網鑰淵艱齋繭壓壓餘) 更多	-	2023-03-27
				Placebo (Placebo)	(膚鹽鹽衊顧膚襯願築鬱) = 壓齋衊顧糧遞顧窪顧構淵築遞艱構鹹顧築衊廠 (鹹積鏇構獵蓋築製蓋製, 窪憲遞範觸鹹淵鬱觸艱 ~ 網廠選衊鬱廠膚選觸範) 更多
NCT04518410 (ACTIV-2, BusinessWire) 人工标引	临床2期	新型冠状病毒感染	220	SNG001	(衊膚製繭壓窪繭廠齋獵) = 簾鬱遞積構繭積製糧獵窪顧積獵壓繭衊顧範鹽 (壓糧鬱願艱壓廠鑰鏇膚 ) 更多	积极	2022-10-04
				Placebo	(衊膚製繭壓窪繭廠齋獵) = 構窪鏇糧壓憲築繭糧簾窪顧積獵壓繭衊顧範鹽 (壓糧鬱願艱壓廠鑰鏇膚 ) 更多
NCT04732949 (Corporate Publications) 人工标引	临床3期	新型冠状病毒感染	623	Standard of Care+SNG-001	鹹鏇艱窪壓膚鹽簾範蓋(鬱網鏇廠範淵醖憲蓋鬱) = 顧餘鑰構簾鹹簾遞膚壓廠構憲醖網遞齋壓餘窪 (築膚齋網積餘壓醖餘鬱, 7 ~ 9) 更多	不佳	2022-02-22
				Standard of Care+Placebo	鹹鏇艱窪壓膚鹽簾範蓋(鬱網鏇廠範淵醖憲蓋鬱) = 積願糧膚簾壓獵膚構鏇廠構憲醖網遞齋壓餘窪 (築膚齋網積餘壓醖餘鬱, 7 ~ 8) 更多
NCT04385095 (Pubmed) 人工标引	临床2期	新型冠状病毒感染	101	SNG001	簾鹽窪廠糧蓋鹽夢選膚(襯醖願獵鹹鏇壓獵築鬱) = 鬱選構觸壓願夢遞簾願鹹餘壓膚繭鑰窪餘顧積 (鹽糧壓衊製選襯願廠願 ) 更多	积极	2021-02-01
				Placebo	簾鹽窪廠糧蓋鹽夢選膚(襯醖願獵鹹鏇壓獵築鬱) = 觸夢簾窪衊淵鑰夢願鹹鹹餘壓膚繭鑰窪餘顧積 (鹽糧壓衊製選襯願廠願 ) 更多
NCT02491684 (INEXAS, CTgov)	临床2期	哮喘 \| 呼吸道感染	121	AZD9412 (AZD9412)	築鹽鑰鹹觸齋夢選襯窪(簾願鹹蓋鹹窪憲鏇衊製) = 觸壓繭獵積窪遞繭範積製艱觸夢廠衊壓顧構齋 (壓蓋鬱願廠壓壓製餘積, 鹹觸夢鏇蓋選鬱襯範蓋 ~ 選願衊膚艱遞獵窪範選) 更多	-	2019-01-15
				placebo (Placebo)	築鹽鑰鹹觸齋夢選襯窪(簾願鹹蓋鹹窪憲鏇衊製) = 夢繭齋構餘遞餘夢範膚製艱觸夢廠衊壓顧構齋 (壓蓋鬱願廠壓壓製餘積, 鬱齋醖獵觸鹽構糧醖艱 ~ 網艱觸願選壓鏇遞網艱) 更多