Biopharmaceutical company Biota Pharmaceuticals has started a Phase II trial of long-acting neuraminidase inhibitor laninamivir octanoate for the treatment of influenza in adults.
Designed to compare the safety and efficacy profile of 40mg and 80mg doses of laninamivir octanoate against placebo, the multinational, randomised trial is expected to enrol 636 subjects.
All subjects with symptomatic influenza A or B infection will be randomised equally across the three treatment arms of the double-blind, placebo-controlled, parallel-arm study, referred to as IGLOO.
Conducted as part of the company's contract with the US Office of Biomedical Advanced Research and Development Authority (BARDA), IGLOO will administer the investigational agent or placebo using a TwinCaps inhaler.
With easing of influenza symptoms as the primary endpoint, the study's secondary endpoints include the determination of laninamivir octanoate's use in reducing the incidence of secondary bacterial infections compared to placebo.
Biota Pharmaceuticals product development vice president Dr John Lambert said the commencement of the multicentre Phase II trial for the treatment of influenza marks an important milestone in the clinical development of laninamivir octanoate.
"We believe that the potential for once-only inhaled dosing of laninamivir octanoate could represent a significant advantage over the five-day, twice-daily dosing associated with the currently marketed neuraminidase inhibitors to treat influenza," Lambert said.
The company expects to have top-line data from the trial in mid 2014.
Image: TEM of negatively stained influenza virions, magnified approximately 100,000 times. Photo: Courtesy of Cynthia Goldsmith.