Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza

Overview

Journal Open Forum Infect Dis

Specialty Infectious Diseases

Date 2019 Apr 27

PMID 31024969

Citations 12

Authors

Grace Roberts

Shuguang Chen

Phillip Yates

Anuradha Madan

Jill Walker

Michael L Washburn

Andrew J Peat

Gary Soucie

Edward Kerwin

Sumita Roy-Ghanta

Affiliations

Soon will be listed here.

Abstract

Background: Danirixin (DNX), a selective and reversible CXC chemokine receptor 2 antagonist, inhibits neutrophil transmigration and activation. This study assessed the safety, tolerability, and clinical effect of DNX with and without oseltamivir (OSV) in adults with acute, uncomplicated influenza.

Methods: This was a placebo-controlled, double-blind, Phase IIa study. Participants (18-64 years) with influenza-like symptoms (onset ≤48 hours) and positive influenza rapid antigen test were randomized 2:1:2:1 to DNX, placebo, DNX+OSV, or OSV (75 mg each, administered twice daily for 5 days) and followed for 28 days. Primary endpoints included frequency of adverse events (AEs) and serious AEs (SAEs). The effect of DNX on virologic response and clinical effect on influenza symptoms were secondary endpoints.

Results: A total of 45 participants were enrolled, 35 of whom were confirmed influenza positive by polymerase chain reaction analysis. The highest incidence of AEs was in the placebo group (4 of 7, 57%), followed by the DNX+OSV (7 of 16, 44%), DNX (3 of 15, 20%), and OSV (0 of 7, 0%) groups. One SAE (T-wave abnormality) was reported in the DNX group (unrelated to treatment). No differences in viral load assessments were observed among treatment groups.

Conclusions: Danirixin treatment was well tolerated and did not impede viral clearance.

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