Bionomics commences clinical trial

Adelaide-based biotechnology company, Bionomics, today announced the initiation of the Phase I clinical trial for its anti anxiety drug, BNC210, to be held at the Royal Adelaide Hospital.

The Phase I clinical trial will be conducted in groups of healthy male volunteers at the Pain and Anaesthesia Research Clinic (PARC) within the Royal Adelaide Hospital and is expected to be completed by calendar year end.

The primary objective of this trial is to evaluate the safety, tolerability and the pharmacokinetics of BNC210. A secondary objective is the preliminary evaluation of central nervous system effect. The results will enable identification of an appropriate dose range for subsequent clinical studies.

"We are very pleased about this early initiation of the Phase I trial of our second drug candidate," said Dr Deborah Rathjen, CEO and Managing Director of Bionomics. "Anxiety is a significant market and represents around US$15 billion revenue per year in the global pharmaceutical sector and yet current treatments do not service patients very effectively. We are excited by the prospect that BNC210 may represent an advance in the treatment of both acute and chronic forms of anxiety.”

BNC210 operates by a novel action to treat anxiety and early indications are that it lacks the side-effects of conventional anxiety treatments, such as sedation, memory loss and addiction. It underwent preclinical and animal trials last year as a precursor to human trials this year.

Current anxiety treatments, such as benzodiazepines (Valium) and selective serotonin reuptake inhibitors (SSRIs, such as Prozac), have various side effects associated with their use. Benzodiazepines offer acute relief to people suffering from anxiety but have sedative, cognitive and motor impairing side effects. In addition, their protracted use can result in tolerance and addiction. SSRIs exhibit slow onset of action (2-4 weeks) and are associated with side effects such as early agitation, gastric disturbances, and sexual dysfunction which preclude their use for the long-term management of anxiety disorders.

The Principal Investigator on the trial is Paul Rolan, Professor of Clinical Pharmacology at the University of Adelaide and a co-founder of PARC. Approval for this trial was granted by the Research Ethics Committee of the Royal Adelaide Hospital in May 2009 and notification given to the Australian regulatory body, the Drug and Safety Evaluation Branch of the Therapeutic Goods Administration (TGA).

The trial design is in accordance with the principles of the International Conference on Harmonization (ICH), standards of conduct for clinical trials that are essentially uniform for all the major regulatory agencies world-wide, including the FDA and Australia ’s TGA.