Biota reports preliminary data from CS-8958 Phase III trial against influenza

Dr Seizaburo Kashiwagi presented the preliminary data from an influenza Phase III prophylaxis study conducted during the 2009/2010 pandemic flu season in Japan. The SHIELD study (Study of Household Influenza prophylaxis Effect of Long-acting anti-influenza Drug) presentation was made at the 59th Annual Meeting of the Japanese Society of Chemotherapy.

SHIELD was a multicenter, placebo-controlled, double-blind trial that evaluated prevention and safety of laninamivir octanoate (CS-8958 or Inavir^®) in families of influenza A and B sufferers. The study measured influenza transmission to other members of the household with a confirmed influenza infected patient. Subjects received one of two dose levels of CS-8958 or placebo. There were no restrictions on other preventative measures undertaken within the household such as the use of masks, hand washing or isolation of the infected patient to a particular room.

The trial demonstrated the protective efficacies of a single, inhaled dose of CS-8958 of 20mg and 40mg as measured by the Risk Reduction Rate (RRR) were 43.7% and 43.2% respectively but were lower than the preset RRR endpoint of 70%.

The possible reasons offered for the lower protective efficacies were the low infection rate within families in the placebo group (8.6%) and the growth in public awareness, resulting in the use of other preventative infection measures during the 09H1N1 pandemic.

Biota will continue to update shareholders when additional trials commence.