A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis

This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study period for each patient will be 27 weeks, during which the patient will undergo screening for up to 21 days, and followed by treatment of 24 weeks and follow up period of 2 weeks. Each patient will be required to make a total of 9 visits.
After re-confirming the eligibility of patients at Visit 2, eligible patients will be randomly assigned to either treatment group or control group in a 2:1 ratio. In addition, patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous injection while patients in the control group will receive placebo solution twice weekly by subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to week 24 and follow up period of 2 weeks.
The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI, BASMI and individual measures of disease activity, such as numbers of swollen and tender joints, ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9. Safety will be evaluated according to the frequency of adverse events, vital signs, physical examination, laboratory abnormalities, and ENIA11 antibody formation.

开始日期2016-09-06

申办/合作机构

永昕生物医药股份有限公司

[+1]

NCT01709760 / Unknown status临床3期

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis

开始日期2012-11-01

申办/合作机构

永昕生物医药股份有限公司

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2024-10-01·Pituitary

Desmopressin dose requirements in patients with permanent arginine vasopressin deficiency: a tertiary center experience

Article

作者: Prencipe, Nunzia ; Gasco, Valentina ; Mocellini, Francesca ; Sibilla, Michela ; Bioletto, Fabio ; Cuboni, Daniela ; Ghigo, Ezio ; Berton, Alessandro Maria ; Grottoli, Silvia ; Varaldo, Emanuele ; Aversa, Luigi Simone

AbstractPurposeThe desmopressin daily dose requirement is highly variable among patients with arginine vasopressin (AVP) deficiency (i.e. central diabetes insipidus) and few studies to date have evaluated this topic, with often inconclusive results. The aim of our study was to identify clinical and biochemical predictors of such dose requirements in a cohort of patients with a confirmed diagnosis of permanent AVP deficiency who have good and stable control under substitutive treatment.MethodsWe retrospectively analyzed data of all patients with permanent AVP deficiency undergoing regular follow-up at our Division. Inclusion criteria were the presence of stable disease under therapy for at least 12 months and in good biochemical and clinical control. Patients with AVP deficiency who lacked intact thirst or had a disease duration of less than 12 months were excluded from the analysis.ResultsOut of the 132 patients initially screened, 96 patients (M/F 44/52; age 51 [37–63] years) met the inclusion criteria. Patients on nasal spray therapy (n = 8) had a significantly longer disease duration (p = 0.002) than patients treated with oral lyophilizate (n = 88). In the bivariate analysis, considering only patients treated with the sublingual formulation, the drug dose was correlated positively with estimated glomerular filtration rate (eGFR) and weight (r = 0.410, p < 0.001; r = 0.224, p = 0.036, respectively) and negatively with age (r = – 0.433, p < 0.001). In the multivariate regression analysis taking into account age, weight, and eGFR, only age emerged as a significant predictor of the required sublingual desmopressin dose (β = – 1.426, p = 0.044).ConclusionOur data suggest that patient age appears to be the primary factor associated with the daily sublingual desmopressin dose required to achieve adequate clinical and biochemical control in patients with permanent AVP deficiency.

2023-08-01·Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi

Serostatus of echovirus 11, coxsackievirus B3 and enterovirus D68 in cord blood: The implication of severe newborn enterovirus infection.

Article

作者: Chang, Luan-Yin ; Lin, Shin-Yu ; Fang, Chi-Tai ; Shih, Jin-Chung ; Hu, Ya-Li ; Chen, Shun-Hua ; Cheng, Ai-Ling ; Lee, Chien-Nan

BACKGROUNDMaternal transplacental antibody is an important origins of passive immunity against neonatal enterovirus infection. Echovirus 11 (E11) and coxsackievirus B3 (CVB3) are important types causing neonatal infections. There were few investigations of enterovirus D68 (EVD68) infection in neonates. We aimed to investigate the serostatus of cord blood for these three enteroviruses and evaluate the factors associated with seropositivity.METHODSWe enrolled 222 parturient (gestational age 34-42 weeks) women aged 20-46 years old between January and October 2021. All participants underwent questionnaire investigation and we collected the cord blood to measure the neutralization antibodies against E11, CVB3 and EVD68.RESULTSThe cord blood seropositive rates were 18% (41/222), 60% (134/232) and 95% (211/222) for E11, CVB3 and EVD68, respectively (p < 0.001). Geometric mean titers were 3.3 (95% CI 2.9-3.8) for E11, 15.9 (95% CI 12.5-20.3) for CVB3 and 109.9 (95% CI 92.4-131.6) for EVD68. Younger parturient age (33.8 ± 3.6 versus 35.2 ± 4.4, p = 0.04) was related to E11 seropositivity. Neonatal sex, gestational age and birth body weight were not significantly different between the seropositive group and the seronegative group.CONCLUSIONCord blood seropositive rate and geometric mean titer of E11 were very low, so a large proportion of newborns are susceptible to E11. The circulation of E11 was low after 2019 in Taiwan. A large cohort of immune naïve newborns existed currently due to lack of protective maternal antibodies. It is imminent to monitor the epidemiology of neonates with enterovirus infections and strengthen the relevant preventive policies.

2022-08-01·The ISME Journal

Bacterial matrix metalloproteases and serine proteases contribute to the extra-host inactivation of enteroviruses in lake water

Article

作者: Kohn, Tamar ; Bachmann, Virginie ; Corre, Marie-Hélène

AbstractEnteroviruses are ubiquitous contaminants of surface waters, yet their fate in presence of microbial congeners is poorly understood. In this work, we investigated the inactivation of Echovirus-11 (E11) and Coxsackievirus-A9 (CVA9) by bacteria isolated from Lake Geneva. Incubation of E11 or CVA9 in biologically active lake water caused inactivation of 2- and 4-log10, respectively, within 48 h. To evaluate the antiviral action of individual bacterial species, we isolated 136 bacterial strains belonging to 31 genera from Lake Geneva. The majority of isolates (92) induced decay of at least 1.5-log10 of CVA9, whereas only 13 isolates induced a comparable inactivation on E11. The most extensive viral decay was induced by bacterial isolates producing matrix metalloproteases (MMPs). Correspondingly, the addition of a specific MMP inhibitor to lake water reduced the extent of inactivation for both viruses. A lesser, though significant protective effect was also observed with inhibitors of chymotrypsin-like or trypsin-like proteases, suggesting involvement of serine proteases in enterovirus inactivation in natural systems. Overall, we demonstrate the direct effect of bacterial proteases on the inactivation of enteroviruses and identify MMPs as effective controls on enteroviruses’ environmental persistence.

项与 Opinercept 相关的新闻（医药）

2021-06-18

·GlobeNewswire

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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适应症	最高研发状态	国家/地区	公司	日期
强直性脊柱炎	临床1期	中国台湾	东生华制药股份有限公司	2016-09-06
强直性脊柱炎	临床1期	中国台湾	永昕生物医药股份有限公司	2016-09-06
类风湿关节炎	药物发现	中国台湾	永昕生物医药股份有限公司	2012-11-01