Alios BioPharma Presented Positive Results of Its Anti-RSV Nucleoside Analog AL-8176 in a Phase 2 Challenge Study in Adults Infected With Respiratory Syncytial Virus (RSV) at IDWeek

SOUTH SAN FRANCISCO, CA--(Marketwired - Oct 13, 2014) - 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 well 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 patients 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."