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Alios
BioPharma, Inc. presented results from a randomized, double-blind,
placebo-controlled Phase 2 challenge study of its oral anti-RSV
nucleoside analog AL-8176 this past weekend at the IDWeek 2014
Conference in Philadelphia, PA. The study was conducted in healthy
adult volunteers who were infected intranasally with respiratory
syncytial virus (RSV). AL-8176 achieved its primary and secondary
endpoints of reduction in viral load (p < 0.0002) and improvement in
symptom scores (p < 0.05) as compared to placebo. AL-8176 was wel
l
tolerated with no discontinuations of study drug and no clinically
significant laboratory abnormalities.
In successfully infected subjects, a rapid and marked reduction in
RSV viral load was observed following treatment in all three AL-8176
treated dose groups as compared to placebo. In contrast, successfully
infected placebo subjects exhibited a logarithmic increase in RSV RNA
with a peak viral load at Day 3.5 following start of dosing with
placebo. The mean time to non-detectability of RSV RNA was 1.3-2.3
days for the AL-8176 treatment groups compared to 7.2 days in the
placebo group. At discharge (Day 12), all subjects treated with
AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable
upon follow-up on Days 16 and 28. The viral load reduction in
infected subjects across all AL-8176 dosing regimens was associated
with concomitant improvements in RSV symptom scores and reductions in
mucus weight.
The Alios study enrolled 62 healthy adult volunteers between the ages
of 18 - 45 who received one of three dose regimens of AL-8176 or
placebo over 5 days: 375 mg orally administered twice daily or 750 mg
given as a single loading dose (LD) followed by twice daily
maintenance doses (MD) of 150 mg or 500 mg. Administration of AL-8176
or placebo was initiated 12 hours after confirmation of RSV infection
as determined by presence of RSV RNA in nasopharyngeal washes.
Thirty-five of the 62 pat
ients met the criterion for infection (ITT-I
population).
The data was presented by John DeVincenzo, MD, Professor of
Pediatrics and Professor of Microbiology, Immunology and Biochemistry
at the University of Tennessee School of Medicine, as part of a
late-breaker session on Saturday, October 11 at the IDWeek 2014
meeting. "These positive data represent a validation of the potent
antiviral effects of an RSV replication inhibitor and further
demonstrate the progress that Alios has made towards developing a
therapy for RSV infections, a disease which affects millions of
children in the US and untold more worldwide," stated Dr. DeVincenzo.
"The ongoing trial assessing the impact of AL-8176 in infants with
RSV is an important next step and will be the first opportunity to
assess efficacy and safety of AL-8176 directly in those who need it
most."
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