Biota Holdings Ltd. has announced the first dose administration in healthy volunteers in its phase Ib clinical trial for its Human Rhinovirus (HRV) drug, BTA798. BTA798 is an antiviral for the treatment of HRV, the common cold virus, known to cause significant clinical complications in sufferers of Asthma and Chronic Obstructive Pulmonary Disease, the fourth leading cause of death in the US.
The phase Ib trial is an ascending, multiple dose, and double-blinded study with oral administration of the drug to 32 healthy volunteers. The primary objective of the trial is to assess the safety and tolerability of BTA798, with a secondary objective to determine the pharmacokinetic properties of the drug over multiple doses.
The phase Ib trial is being conducted in the UK with the acceptance of the Medical and Healthcare Products Regulatory Agency (MHRA) and the Independent Ethics Committee (IEC). The phase Ib trial is the second of two parts of the phase I clinical trial that commenced in February 2006. Phase Ia was successfully completed with BTA798 found to be safe and well tolerated in healthy volunteers.
Biota is a world-leading antiviral drug development company based in Melbourne, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, and subsequently marketed by GlaxoSmithKline (GSK) as Relenza. Relenza is currently being stockpiled by a number of national governments for defense against avian influenza.