tetano
Editor, Senior Moderator
J Infect Dis. 2012 Oct 8. [Epub ahead of print]
A Phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection.
Moss RB, Hansen C, Sanders RL, Hawley S, Li T, Steigbigel RT.
Source
NexBio Inc, San Diego CA.
Abstract
Background. DAS181, a novel host directed antiviral in development for influenza treatment, was assessed in this Phase II clinical trial.Methods. This study was a double blind, placebo controlled Phase II clinical trial assessing influenza viral load and patient safety in otherwise healthy influenza infected subjects. Subjects were randomized to a single-dose, multiple-dose or placebo group, and were followed for safety and virologic outcomes.Results. A total of 177 laboratory confirmed influenza infected subjects were enrolled in the trial encompassing 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemisphere. Thirty seven percent of subjects had confirmed infection with influenza B, 33% seasonal H3N2, 29% Pandemic 2009 H1N1, and 1 subject was positive for both influenza B and Pandemic 2009 H1N1. Significant effects were observed in regard to decreased change from baseline viral load and viral shedding in the multiple-dose group compared to placebo as measured by quantitative PCR (P<0.05). No instances of H274Y were observed among viral isolates from this trial. Overall, the drug was generally well tolerated.Conclusions. DAS181 significantly reduced viral load in subjects infected with influenza, thus warranting future clinical development of this novel host-directed therapy.
PMID:
23045618
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23045618
A Phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection.
Moss RB, Hansen C, Sanders RL, Hawley S, Li T, Steigbigel RT.
Source
NexBio Inc, San Diego CA.
Abstract
Background. DAS181, a novel host directed antiviral in development for influenza treatment, was assessed in this Phase II clinical trial.Methods. This study was a double blind, placebo controlled Phase II clinical trial assessing influenza viral load and patient safety in otherwise healthy influenza infected subjects. Subjects were randomized to a single-dose, multiple-dose or placebo group, and were followed for safety and virologic outcomes.Results. A total of 177 laboratory confirmed influenza infected subjects were enrolled in the trial encompassing 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemisphere. Thirty seven percent of subjects had confirmed infection with influenza B, 33% seasonal H3N2, 29% Pandemic 2009 H1N1, and 1 subject was positive for both influenza B and Pandemic 2009 H1N1. Significant effects were observed in regard to decreased change from baseline viral load and viral shedding in the multiple-dose group compared to placebo as measured by quantitative PCR (P<0.05). No instances of H274Y were observed among viral isolates from this trial. Overall, the drug was generally well tolerated.Conclusions. DAS181 significantly reduced viral load in subjects infected with influenza, thus warranting future clinical development of this novel host-directed therapy.
PMID:
23045618
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23045618