Biota Reports Top-Line Data From Its Phase 2 "IGLOO" Trial of Laninamivir Octanoate
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 (p=0.248 and p=0.776, respectively), 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 (p < 0.001) and 80 mg (p=0.070) 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 (p=0.002) and 80 mg (p=0.020) 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 (p=0.013). The nature and extent of adverse events were similar in the three cohorts, with diarrhea (3.1% vs. 0.9%), headache (1.4% vs. 0.5%), gastritis (1.4% vs. 0%), urinary tract infection (1.4% vs. 0%), and sinusitis (1.2% vs. 0.9%) being the most common adverse events that occurred more frequently in the treatment cohorts as compared to placebo. The incidence of serious adverse events was low and balanced across the three cohorts.
"It is disappointing that the rapid and significant onset of antiviral activity against the influenza virus that the two treatment arms demonstrated with LANI did not translate into a meaningful reduction in the time to alleviate patient-reported influenza symptoms," stated
The Company plans to provide a detailed update on the full efficacy and safety results of the Phase 2 IGLOO trial, the status of the LANI program and its corporate strategy during its fourth quarter and fiscal year-end earnings call in early September.
About Laninamivir Octanoate (LANI)
Laninamivir octanoate is a second-generation octanoyl ester prodrug of laninamivir that has demonstrated in vitro neuraminidase-inhibitory activity against influenza A and B viruses, including subtypes N1 to N9, swine origin H1N1 strains and oseltamivir-resistant viruses. Laninamivir octanoate has long-lasting antiviral activity and exhibits a calculated half-life of approximately 58 hours in the respiratory tract. In a previous Phase 3 clinical trial, a single 40 mg inhaled dose of laninamivir octanoate exhibited efficacy similar to that of daily repeated doses of oseltamivir phosphate.
In 2003, the Company and Daiichi Sankyo cross-licensed intellectual property related to long-acting neuraminidase inhibitors, of which the lead product, laninamivir octanoate, has been successfully developed and subsequently marketed in
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve known and unknown risks and uncertainties. Any statements that are not historical facts may be deemed to be forward-looking statements, including statements related to the timing of additional clinical, safety and pharmacokinetic data from the IGLOO Phase 2 trial, the Company's current plan to not independently advance the development of LANI for the treatment of influenza, the Company's intent to evaluate next steps for the LANI program outside of
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Russell H. PlumbChief Executive Officer (678) 221-3351 email@example.com Lee M. Stern The Trout Group(646) 378-2922 firstname.lastname@example.org
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