Biota's HRV drug successful in first phase of trial
The Phase Ia trial of Biota Holdings" human rhinovirus (HRV) drug has been successful and the drug has received Independent Ethics Committee approval to move into phase Ib.
The Phase Ia trial of Biota Holdings" human rhinovirus (HRV) drug has been successful and the drug has received Independent Ethics Committee approval to move into phase Ib.
BTA798, developed by the Australian antiviral specialist, is 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 first of two parts of the Phase I clinical trial commenced in February 2006 and was conducted in the UK as an ascending single dose, double-blind oral study, in 24 healthy volunteers. BTA798 was demonstrated to be safe and generally well tolerated in humans.
The IEC has approved an ascending, multiple dose, double-blind Phase Ib study that will examine the safety and tolerability of dosing for up to seven days, at dose levels expected to be efficacious in man. It is scheduled to commence in August 2006.
Biota ceo Peter Cook said: "While still early in the overall clinical programme, the result supports our decision to take BTA798 into the clinic. Progress through human trials should create substantial addi-tional value for shareholders and can be adequately funded through Biota's improved financial position".