A phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection.

J Infect Dis. 2012 Dec 15;206(12):1844-51.

Moss RB, Hansen C, Sanders RL, Hawley S, Li T, Steigbigel RT.

NexBio Inc, San Diego California 92121, USA. rmoss@nexbio.com

 

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 participants. Participants 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 participants were enrolled in the trial, which encompassed 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemispheres. Thirty-seven percent of participants had confirmed infection with influenza B, 33% with seasonal H3N2, 29% with pandemic 2009 H1N1, and 1 participant 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 with placebo as measured by quantitative polymerase chain reaction (P < .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 participants infected with influenza, thus warranting future clinical development of this novel host-directed therapy. CLINICAL TRIALS.GOV IDENTIFIER: NCT01037205.

PMID: 23045618

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