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吉利德呼吸道合胞病毒药物GS-5806 IIa研究达主要终点

来源:生物谷 2014-05-21 18:11

2014年5月21日讯 /生物谷BIOON/ --吉利德科学(Gilead Sciences)5月20日公布了实验性药物GS-5806的一项IIa期攻毒研究数据。该项研究在鼻内感染呼吸道合胞病毒(RSV)的健康成人患者中开展,GS-5806是一种实验性口服RSV膜融合抑制剂。研究数据表明,与安慰剂相比,GS-5806使病毒载量(洗鼻夜中检测的病毒总量)降低了99.9%(p<0.001),改善了总的粘液重量(鼻子产生的粘液量,p=0.028),改善了症状日记得分(p=0.005),达到了研究的主要终点和次要终点。相关数据已提交至在圣地亚哥举行的美国胸科学会(ATS)2014年会。

呼吸道合胞病毒(RSV)是一种病原体,可感染人体呼吸道,可能导致支气管炎和肺炎。尽管大多数健康人能够恢复,但在早产儿、患肺部疾病的个体、老年人、免疫抑制群体中可导致严重的疾病和死亡。在全球范围内,RSV感染导致的临床负担与流感相当。研究中中无严重不良事件。所有的不良事件均为轻度或中度。

目前,针对RSV,还没有有效的抗病毒药物,这也是导致严重呼吸道感染的重要原因。

关于GS-5806:

GS-5806是一种口服小分子抗病毒膜融合抑制剂,目前正调查用于呼吸道合胞病毒(RSV)的治疗。据认为,GS-5806通过抑制RSV F介导的RSV RNA融合,阻断RSV的复制。GS-5806是一种实验性药物,其安全性和疗效尚未确定。(生物谷Bioon.com)

英文原文:Gilead Sciences, Inc. (GILD) Reports GS-5806 Met Primary, Secondary Endpoint in Phase i2a

May 20, 2014 5:04 PM EDT

Gilead Sciences, Inc. (Nasdaq: GILD) announced results from a placebo-controlled, Phase 2a challenge study in healthy adult patients intranasally infected with respiratory syncytial virus (RSV). The study of GS-5806, an investigational oral RSV fusion inhibitor, achieved its primary and secondary endpoints of lower viral load (the amount of virus detected in the nasal wash), improvements in total mucus weight (the amount of mucus produced by the nose) and also symptom diary score compared to placebo. Detailed results from this study (Poster #1008) will be presented today during a poster discussion session at the American Thoracic Society 2014 International Conference in San Diego.

RSV is a pathogen that infects the human respiratory tract, potentially leading to bronchiolitis and pneumonia. While most otherwise healthy people recover from the virus, there is an increased risk of severe disease and death in premature infants, individuals with certain pulmonary diseases, the elderly and those who are immune suppressed. Globally, the clinical burden of RSV infection is comparable to that of influenza.

“No effective antiviral treatment currently exists for RSV infection, which is a major cause of serious respiratory infections,” said John DeVincenzo, MD, Professor of Pediatrics and Professor of Microbiology, Immunology, and Biochemistry, University of Tennessee School of Medicine and Medical Director of the Molecular and Viral Diagnostics Laboratories at Le Bonheur Children's Hospital. “Based on the reductions in RSV viral load and clinical symptoms, as well as the safety profile observed in this adult challenge study, clinical trials in naturally infected patients should now be explored.”

The primary efficacy analysis focused on the pre-specified quarantine phase of the study (Cohorts 1-4) of healthy volunteers with demonstrated RSV infection before treatment. Among 54 patients in Cohorts 1-4 (GS-5806: n=27; placebo: n=27), GS-5806 treatment resulted in a 99.9 percent reduction in the viral load (expressed as log transformed viral load area under the curve of 250.7 log10 plaque forming unit equivalents (PFUe*) hour/mL versus 757.7 log10 PFUe*hour/mL; p<0.001).

Mean total mucus weight after treatment and mean change from baseline total symptom diary score (daily reporting of symptoms such as stuffy nose, cough and sore throat) also were significantly lower for GS-5806-treated patients. Mean total mucus weight during the five days after the first dose was 6.9 g for GS-5806 compared to 15.1 g for placebo-treated patients, a treatment difference of 8.2 g (p=0.028). Adjusted mean AUC of change in symptom diary score from after first dose through Day 12 was -20.2 for patients treated with GS-5806 compared to 204.9 score*hour for placebo-treated patients, a difference of 225.1 score*hour (p=0.005).

There were no serious adverse events in the study. All adverse events were mild or moderate in severity, with the exception of one patient who received placebo. Grade 1 pulmonary function decrease was the only treatment-emergent adverse event experienced by two or more patients in either treatment group.

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