Daiichi Sankyo Initiates Phase III Trial For CS-8958

Daiichi Sankyo has launched a new Phase III trial of its anti-influenza agent, CS-8958. The company’s goal is to gain an influenza prevention indication in Japan. The trial is named SHIELD (a Study of Household Influenza prophylaxis Effect of Long-acting anti-influenza Drug).

CS-8958, a novel neuraminidase inhibitor discovered by Daiichi Sankyo for the treatment of influenza is co-owned with Biota Holdings, and is a laninamivir prodrug. The inhaled formulation will be single-administered, acting directly on the trachea and lungs to inhibit influenza.

Reportedly, the trial is placebo-controlled, double-blind and is expected to evaluate preventive effect and safety of CS-8958 in families of influenza A and B sufferers. Daiichi Sankyo will measure influenza transmission among those receiving CS-8958 or placebo. The company expects to observe that inhaled CS-8958 administered once weekly shows the prophylaxis effect.

The company is pressing ahead with the development program of CS-8958 in Japan. Moreover, the company is preparing to submit an application for manufacturing and marketing approval by March 2010 to the Japanese Ministry of Health, Labour and Welfare for CS-8958 to treat adult and pediatric patients.