TOYAMA SUBMITS IND FOR AVIAN FLU DRUG

Toyama Chemical has submitted an investigational new drug (IND) application to the FDA for its influenza drug T-705.

T-705 is a unique viral RNA polymerase inhibitor discovered by Toyama Chemical. Studies conducted under contract with the National Institute of Allergy and Infectious Disease demonstrated that T-705 has exceptionally potent activity in mouse infection models of H5N1 avian influenza. Toyama is currently developing T-705 as a treatment for influenza infections including infections with H5N1 strains.

Currently, the only antiviral agents approved to treat influenza infection are neuraminidase inhibitors. However, there are concerns over the emergence of virus strains resistant to these drugs, and there is no demonstrated utility for these drugs in treating H5N1 avian influenza, according to Toyama. Under such circumstances, the development of T-705, which has a different mechanism of action, would provide physicians and patients with alternative treatment options to the current therapies.

Phase I clinical studies began last week in Japan. Development in Japan and the U.S. will be carried out in parallel.