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August 1, 2014
07:28 EDTBOTABiota reports IGLOO did not achieve significant reduction in time to alleviation
Biota Pharmaceuticals announced top-line data from a randomized, double-blind, placebo-controlled, parallel-arm Phase 2 clinical trial comparing the safety and efficacy of a 40 mg and 80 mg dose of laninamivir octanoate, or LANI, to placebo. The trial, referred to as IGLOO, enrolled 639 patients across 12 countries in the Northern and Southern Hemisphere from June 2013 to April 2014. Of the 639 patients enrolled, 248, or 39%, had PCR confirmed influenza A or B virus and were included in the intent-to-treat efficacy analyses. Approximately 75% and 19% of the influenza-confirmed patients were infected with influenza A H1N1 2009 and H3N2, respectively, with 6% being infected with influenza B. As compared to placebo, neither the 40 mg or 80 mg cohort achieved a statistically significant reduction in the median time to alleviation of influenza symptoms as measured by the Flu-iiQ patient-recorded outcome questionnaire, which was the primary endpoint of the study. The median time to alleviation of influenza symptoms was 102.3 hours for the 40 mg cohort and 103.2 hours for the 80 mg cohort, as compared to 104.1 hours for the placebo cohort. Patients in both the 40 mg and 80 mg cohorts demonstrated a statistically significant reduction in viral shedding on Day 3 of the study compared to placebo as quantified by qRT-PCR. In addition, a statistically significant proportion of patients in both the 40 mg and 80 mg cohorts were culture negative on Day 3 of the study as compared to placebo. Influenza-infected patients in the 40 mg cohort also demonstrated a statistically significant reduction in the incidence of secondary bacterial infections as compared to placebo.
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