Biota starts RSV trial

Australia's Biota and US biotech MedImmune have commenced a Phase Ia clinical trial for their respiratory syncytial virus (RSV) antiviral drug, BTA9881.

Developed from original research by Biota, the drug was licensed to MedImmune in 2005.

The trial is an oral, single dose escalating, double-blinded, placebo-controlled study in 72 healthy adult volunteers.

The primary objective of the trial is to assess the safety and tolerability of BTA9881, with a secondary objective to determine its pharmacokinetic properties in adults.

It is being conducted with acceptance by an Independent Ethics Committee (IEC) for the clinical trial centre and by notification to the Australian Therapeutic Goods Administration. Results of the study are expected by the end of 2007.

Under the terms of the licensing agreement, MedImmune is to provide Biota with a US$3 million payment upon the initiation of the trial.

BTA9881 is a small molecule fusion inhibitor, designed to specifically inhibit the process by which RSV infects a cell. The drug will be used to stop replication of RSV in an infected patient with the aim of clearing the infection or reducing the clinical effect of the disease.