Being conducted under the company’s contract with the US Office of Biomedical Advanced Research and Development Authority (BARDA), the multi-national, double blind trial will enroll 636 subjects and randomize them equally into three treatment arms.
With top-line data expected in mid-2014, the parallel arm study will use a TwinCaps inhaler to deliver the long-acting neuraminidase inhibitor laninamivir octanoate or the placebo into the subjects.
Time to easing of influenza symptoms is the primary end point and the determination of laninamivir octanoate’s use in reducing the incidence of secondary bacterial infections versus placebo form the secondary end points.
Biota Pharmaceuticals product development vice president Dr. John Lambert said the commencement of the multi-centre Phase 2 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 added.