Inavir laninamivir octanoate: Phase II data
Top-line data from 248 patients with PCR-confirmed influenza A or B infection in the intent-to-treat (ITT) population of the double-blind, international Phase II IGLOO trial showed that 40 and 80 mg laninamivir octanoate delivered via TwinCaps dry-powder inhaler each missed the primary endpoint of improving median time to alleviation of influenza symptoms as measured by the Flu-iiQ patient-recorded outcome questionnaire vs. placebo. Specifically, median time to alleviation of influenza symptoms was 102.3 hours in the 40 mg cohort (p=0.248) and 103.2 hours in the 80 mg cohort (p=0.776) vs. 104.1 hours for placebo.
Laninamivir octanoate reduced viral shedding as measured by quantitative real-time PCR on day 3 at both the 40 (p<0.001) and 80 mg (p=0.07) doses vs. placebo. Additionally, a significantly greater proportion of patients receiving 40 (p=0.002) and 80 mg (p=0.02) laninamivir octanoate were culture negative at day 3 vs. placebo. Furthermore, 40 mg laninamivir octanoate significantly reduced the incidence of secondary bacterial infections vs. placebo (p=0.013). The most common adverse events reported more frequently with laninamivir octanoate than placebo were diarrhea, headache, gastritis, urinary tract infection and sinusitis. The trial enrolled 639 patients who presented with symptomatic presumptive influenza A or B infection. ...