The goal is to gain an influenza prevention indication in Japan. CS-8958 is a prodrug and administered by inhalation. Once inhaled it is converted to the active metabolite known as laninamivir. To date, the development of this product has focused on treatment of influenza patients and the new study examines its use in prevention.
This Phase III study is a multicenter, placebo-controlled, double-blind trial that will evaluate prevention and safety of CS-8958 for families of influenza A and B sufferers. The study measures influenza transmission among those receiving CS-8958 or a placebo. It will be conducted in Japan and subjects will be enrolled from household’s with influenza infected patients. The trial is a Study of Household Influenza prophylaxis Effect of Long-acting anti-influenza Drug, with the acronym of SHIELD.
SHIELD is also intended to establish the optimum dosage of CS-8958 for this indication and provide a further evaluation of safety. Intra-group comparisons will be made with regard to the incidence of adverse events and other safety measures.
Laninamivir is a novel neuraminidase inhibitor discovered by Daiichi Sankyo for the treatment of influenza and is co-owned with Biota Holdings Limited. Daiichi Sankyo is pressing ahead with the development program of CS-8958 in Japan. An application for manufacturing and marketing approval is planned to be submitted by March 2010 for the treatment of adult and paediatric influenza utilising the results of the Phase III therapeutic trial completed in June 2009.