Research Project
6844233
DESCRIPTION (provided by applicant): The application aims to develop a novel Influenza neuraminidase inhibitor (NAI) for protection and treatment of those exposed to a deliberately released, highly pathogenic strain of Influenza virus. The antiviral drug would also have complementary value in the event of a natural pandemic. The drug will be administered using a nebulizer in a single dose for therapy and once a week for prophylaxis. Current therapies for lnfluenza, including vaccines, cannot provide such a practical and immediately available protection from the threat of a potentially lethal Influenza virus. Biota Holdings Ltd developed the first-in-class NAI drug, Relenza (tm), through a partnership with GlaxoSmithKline (GSK). Although Relenza is considered to be safe and is effective for all existing Influenza NA variants, it and other anti-Influenza drugs have features that are less than ideal for mass treatment/prophylaxis in the event of a bioterrorist attack. In particular, pharmacokinetic limitations require that existing drugs be administered repeatedly during the period of exposure or treatment, which presents challenges in supply and compliance during a biodefense or a pandemic situation. Biota in collaboration with Sankyo Co. Ltd. have identified a new class of Long Acting Neuraminidase Inhibitors (LANI), and have advanced a representative LANI compound (R-118958) through completion of a Phase I human clinical safety study demonstrating pharmacokinetics consistent with once weekly dosing. In this study the drug was delivered via a dry powder inhaler. For biodefense a nebulized delivery of the drug would be favored as it would allow long term storage of a very active drug substance in bulk form. Formulation for nebulized delivery is a well recognized practice, readily conducted by pharmacists and healthcare professionals and would allow timely delivery to a population exposed to a bioterror agent. This application aims to conduct the studies required for development of a convenient nebulized form of R-118958.
