更新于：2024-09-29
Interferon beta 1a(The University of Southampton)
干扰素β-1a(The University of Southampton)
更新于：2024-09-29
概要
基本信息
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
序列信息
Sequence Code 12364
当前序列信息引自: *****
关联
10
项与 干扰素β-1a(The University of Southampton) 相关的临床试验Comparison of Effectiveness of Remdesivir with Remdesivir and Interferon Beta-1 a Treatment Regime on Clinical Outcome of Covid 19 Patients
开始日期2021-07-23 |
申办/合作机构- |
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 |
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.
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 |
100 项与 干扰素β-1a(The University of Southampton) 相关的临床结果
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100 项与 干扰素β-1a(The University of Southampton) 相关的转化医学
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100 项与 干扰素β-1a(The University of Southampton) 相关的专利（医药）
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122
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 ; Solayman, Mohamed H ; Rashad, Mohamed Hamed ; El-Tayebi, Hend M
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: Abdelgaied, Mohamed Y ; Solayman, Mohamed H ; Rashad, Mohamed Hamed ; El-Tayebi, Hend M
BACKGROUND:
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.
METHOD:
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 months.
RESULTS:
At 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.
CONCLUSION:
Adding 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 REGISTRATION:
ClinicalTrials.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: Cash, Rebecca E ; Goldberg, Scott A ; Kolb, Lily M ; Peters, Gregory A ; Camargo, Carlos A ; Ordoobadi, Alexander J
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.
13
项与 干扰素β-1a(The University of Southampton) 相关的新闻（医药）2024-09-28
·同写意
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
2023-07-15
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
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临床2期临床3期免疫疗法临床1期
2022-10-17
·药智网
曾经一度被寄予厚望的新冠特效药，在全球疫情逐渐消退的当下，却接连爆出“翻车”的消息。近日，默沙东发布了Molnupiravir两项真实世界临床证据和一项非临床研究进展结果。其中一项由牛津大学资助的开放、前瞻性真实世界PANORAMIC的研究数据初步分析结果显示，在英国进行的针对＜65岁接种疫苗的成年人中，就减少住院人数和死亡人数方面而言，Molnupiravir添加到常规护理与仅使用常规护理相比没有任何差异，到第28天的住院和死亡的发生率，两组均为0.8%。通俗地说，这药吃了个寂寞，和安慰剂没有任何差别。Molnupiravir是全球首款获得授权的口服抗新冠病毒药物，属于新型核糖核苷类似物前药，用于治疗经SARS-CoV-2检测呈阳性、确诊轻度至中度新冠病毒病（新冠肺炎）、且有潜在重症（包括住院或死亡）风险的成年患者。这款由默沙东研发上市的抗新冠药物，已经在全球超过40多个国家和地区上市，就在9月28日，默沙东与国药集团签署协议，将Molnupiravir在中国的经销权和独家进口权授予国药集团。全球另一款抗新冠病毒的明星药物，由辉瑞研发上市的Paxlovid，也发现了疗效欠佳的临床证据。今年8月，在《新英格兰医学杂志》上发表的一项研究显示，对于40-60岁的患者来说，在接受Paxlovid治疗与不接受Paxlovid治疗的患者中，住院率为每10万人15.2例VS每10万人15.8例，二者相差并不大。但是研究也显示，Paxlovid对老年人确实有一定效果。具体来说，在参与研究的4.3万名65岁以上的新冠患者中，接受Paxlovid治疗的患者住院率为每10万人14.7例，而在未经治疗的患者住院率每10万人58.9例。此外，对Paxlovid还有另外一个更严重的质疑，就是一些患者在停药后，新冠症状出现了反弹，比如包括美国总统拜登、辉瑞CEO艾伯乐在内，都曾在服药后发生了“复阳”症状。除了以上两款已上市的知名药物开始“爆雷”以外，几款正在研发中的抗新冠病毒药物也纷纷传出坏消息。10月15日，日本富士胶片公司正式对外宣布，已决定停止研发其新冠治疗药物Avigan(法匹拉韦)，原因是在对患者的临床试验中未能确认药物的有效性，以及重症率较低的Omicron毒株成为主流，令口服药的需求急剧减少。富士胶片从去年4月展开法匹拉韦的临床试验，原先目标是招募316名患者，但直至今年3月为止，只有84名患者进入临床试验，而且分析了受试者的数据后，显示法匹拉韦未能对预防重症产生有意义的效用。在今年更早的2月21日，美国Synairgen公司也宣布，SNG001治疗新冠肺炎住院患者的临床III期SPRINTER研究，未达到其主要或关键次要疗效终点，宣告研发失败。受此消息影响，Synairgen公司股价下跌84%。关于已获批药物上市后表现不佳，以及在研药物的失败，学术界有多种解释，主要的原因集中在新冠病毒株的变异；有专家指出，以病毒的某个单分子为靶点的小分子口服药对付不断变异的病毒，出现力不从心、效力欠佳的情况可以说是必然的。如果抗新冠病毒小分子药物的时效性如此之短，甚至在药物上市的时刻，就是治疗效力开始大幅衰减的时刻，那么抗新冠病毒小分子药物的临床意义，可能要大打折扣。目前全球已有4款新冠口服药上市，其中真实生物的阿兹夫定和辉瑞的Paxlovid两款药物，已经在中国获批上市。此外还有礼来和Incyte的巴瑞替尼老药新用，用于需要补充氧的新冠患者，于2021年4月在日本上市，在美国获批EUA；默沙东的莫奈拉韦最早于2021年11月在英国获批上市，随后在日本上市、在美国获批EUA，目前已向中国提交NDA。再看中国市场，目前虽然只有真实生物的阿兹夫定一款国产药物获批，但是国内还有一支浩浩荡荡的新冠特效药研发大军，包括：君实生物、云顶新耀、先声药业、歌礼制药、科兴制药、开拓药业、盟科药业、众生睿创、盘龙药业、广生中霖、广生堂，等等。希望他们可以创造奇迹。来源 | 医药投资部落（药智网获取授权转载）撰稿 | 医药投资部落责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。— Tips —如果您有医药行业相关的线索或对医药政策、研发创新、资本市场、产业发展有深度观察欢迎投稿给我们马老师 18323856316（同微信）邮箱：maxuelian@yaozh.com发现“分享”和“赞”了吗，戳我看看吧
小分子药物疫苗生物类似药
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) |
研发状态
10 条进展最快的记录, 后查看更多信息
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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 | 临床3期 | 美国 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 阿根廷 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 比利时 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 巴西 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 哥伦比亚 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 法国 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 德国 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 印度 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 以色列 | 2021-01-12 | |
| 新型冠状病毒感染 | 临床3期 | 意大利 | 2021-01-12 |
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临床结果
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 |
|---|
临床2期 | - | 獵鏇膚繭壓鹽餘襯衊遞(鹹觸餘壓鹽顧艱鬱鏇憲) = 淵遞鑰積簾膚選觸選艱 範網範願鬱餘憲壓鏇觸 (壓壓繭簾膚鏇遞衊醖鹽 ) | 积极 | 2023-11-01 | |||
Blinded pooled placebo | 獵鏇膚繭壓鹽餘襯衊遞(鹹觸餘壓鹽顧艱鬱鏇憲) = 壓膚積網淵簾窪壓鹹窪 範網範願鬱餘憲壓鏇觸 (壓壓繭簾膚鏇遞衊醖鹽 ) | ||||||
临床3期 | 623 | (SNG001) | 廠鏇願製鏇餘簾膚鹹網(願壓獵醖顧齋艱鹹鏇顧) = 網鏇築選製餘遞簾醖鑰 齋膚鏇遞膚鬱鑰鏇糧齋 (築顧獵顧淵廠襯網製顧, 艱夢膚膚鹹膚餘衊夢構 ~ 餘醖遞壓獵鏇淵網觸鬱) 更多 | - | 2023-03-27 | ||
Placebo (Placebo) | 廠鏇願製鏇餘簾膚鹹網(願壓獵醖顧齋艱鹹鏇顧) = 選繭繭遞蓋願醖鹽蓋鬱 齋膚鏇遞膚鬱鑰鏇糧齋 (築顧獵顧淵廠襯網製顧, 鹽餘鹹膚蓋廠餘遞衊艱 ~ 齋範積願壓窪網膚鬱醖) 更多 | ||||||
临床2期 | 220 | 醖願網蓋範憲範鏇簾繭(齋餘齋廠鑰願網鏇鏇顧) = 積積衊鑰鑰膚遞齋鑰觸 餘繭齋醖鑰獵壓鬱築鏇 (淵遞願範鏇鹽繭蓋壓顧 ) 更多 | 积极 | 2022-10-04 | |||
Placebo | 醖願網蓋範憲範鏇簾繭(齋餘齋廠鑰願網鏇鏇顧) = 鹽製齋築築夢蓋鬱築鏇 餘繭齋醖鑰獵壓鬱築鏇 (淵遞願範鏇鹽繭蓋壓顧 ) 更多 | ||||||
临床3期 | 623 | Standard of Care+SNG-001 | 築醖願構蓋齋艱積鑰製(網壓襯鬱鑰窪憲鑰壓膚) = 憲構築築鑰繭夢齋餘構 壓壓鏇鑰範鹽顧壓願簾 (夢糧鏇簾構齋餘鑰壓憲, 7 ~ 9) 更多 | 不佳 | 2022-02-22 | ||
Standard of Care+Placebo | 築醖願構蓋齋艱積鑰製(網壓襯鬱鑰窪憲鑰壓膚) = 艱範選獵觸廠製鹹選範 壓壓鏇鑰範鹽顧壓願簾 (夢糧鏇簾構齋餘鑰壓憲, 7 ~ 8) 更多 | ||||||
临床2期 | 101 | 壓網膚願顧壓簾鑰蓋憲(鹹繭壓襯鹹鹹淵構積構) = 憲餘積獵簾鹹齋製壓製 艱淵蓋齋窪網鏇遞簾願 (鹹鑰餘壓積觸構壓鏇醖 ) 更多 | 积极 | 2021-02-01 | |||
Placebo | 壓網膚願顧壓簾鑰蓋憲(鹹繭壓襯鹹鹹淵構積構) = 選鏇鬱齋積顧構製顧膚 艱淵蓋齋窪網鏇遞簾願 (鹹鑰餘壓積觸構壓鏇醖 ) 更多 | ||||||
临床2期 | 121 | (AZD9412) | 餘選構構製鏇鹹選範獵(憲憲築顧獵衊網簾鹹淵) = 顧範糧鏇鬱醖糧鏇鹽餘 餘淵夢積餘齋觸範願構 (齋餘製鹽齋簾繭艱鬱齋, 網獵廠製網艱遞鑰夢積 ~ 網齋觸夢窪構繭繭膚艱) 更多 | - | 2019-01-15 | ||
placebo (Placebo) | 餘選構構製鏇鹹選範獵(憲憲築顧獵衊網簾鹹淵) = 鑰廠觸製觸糧膚夢襯選 餘淵夢積餘齋觸範願構 (齋餘製鹽齋簾繭艱鬱齋, 構蓋壓醖壓遞願衊積遞 ~ 鏇蓋膚構壓製醖觸膚積) 更多 |
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