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VX-787 Showed Significant Antiviral Activity And Reduced The Severity And Duration Of Influenza Symptoms In Phase 2 Challenge Study

The primary objective of this study was to determine the effect of VX-787 on levels of the influenza virus by measuring the total area under the curve of viral titers (quantity of the virus shed in nasal secretions) over time. Viral shedding is a validated marker for assessing antiviral agents in proof-of-concept clinical studies in influenza. Higher total area under the curve (AUC) indicates greater shedding of the influenza virus from the upper respiratory tract, whereas lower total AUC indicates inhibition of, or decreased, viral shedding.

Secondary objectives of the study included safety and tolerability, as well as duration and severity of clinical symptoms. In the study, only people who developed influenza infection after exposure, as measured by detectable virus in nasal secretions or a pre-defined antibody response, were included in the efficacy analysis, whereas all study participants were included in the safety analysis. Of the 72 patients enrolled across the VX-787 treatment arms, 52 developed influenza infection. Of 32 patients enrolled in the placebo arm, 22 developed influenza infection.

Efficacy Data

Primary Endpoint: Across the VX-787 doses studied, a statistically significant dose response in reduction in viral shedding AUC was observed (p=0.036). In addition, over the seven days of observation, the 14 people in the highest dose group showed a total median AUC of 0.4 log 10 virus compared to the 22 people who received placebo, who showed a total median AUC of 5.9 log 10 virus, a difference that was statistically significant. These median AUC values reflect a 94 percent reduction in the amount of virus shed during the study for people treated with the highest dosing regimen of VX-787 compared to placebo.

Secondary Endpoints: In addition to reductions in total viral AUC, treatment with VX-787 in the highest dose group also resulted in statistically significant improvements in multiple clinical measures of influenza. People in this group experienced influenza-like symptoms for a median duration of 1.9 days, compared to 3.7 days for those who received placebo. In addition, there was a statistically significant decrease in the severity of influenza-like symptoms, as measured by AUC and peak severity of symptoms reported by participants in the study. Participants graded seven influenza-like symptoms on a scale of 0 to 3; this was summed to obtain a symptom severity score (maximum symptom severity score of 21.)

                     
Influenza-Like Symptoms     Placebo (n=22)    

1,200 mg / 600 mg* (n=14)

Peak (mean; severity score)     3.4    

1.4**

Duration (median; days)     3.7    

1.9**

AUC (median; severity score over 7 days)     4.1    

1.8**

* First dose was 1,200 mg for one day, subsequent doses were 600 mg QD for four days

** Statistically significant; p<0.05 

 

Safety Data

In this study, VX-787 was generally well-tolerated, and all participants completed treatment. There were no serious adverse events or adverse events that led to discontinuation of treatment. Overall, the most frequently reported class of adverse events in the VX-787 and placebo arms were those typically associated with influenza-like illness. In the development program to date, VX-787 has been dosed in approximately 170 people. The highest single dose given was 1,600 mg, and the longest duration of dosing was 800 mg QD for 10 days. In these studies, there were no serious adverse events, and no adverse events that led to treatment discontinuation.

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