Valium and Prozac Up for Australian Drug Challenge
Adelaide, Australia: Bionomics Limited (ASX:BNO) today announced the initiation of the Phase I clinical trial for its anti anxiety drug,
BNC210. The promising preclinical profile of BNC210 indicates that it is fast-acting and lacks the side-effects seen
with current anxiety treatments and may offer the same or greater therapeutic benefit.
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.
Dr Deborah Rathjen, CEO and Managing Director of Bionomics said “We are very pleased about this early initiation of the
Phase I trial of our second drug candidate. 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
The potent anxiolytic activity of BNC210 and lack of side effects has been identified in extensive preclinical studies
across a broad range of models. Current anxiety treatments, such as benzodiazepines (Valium) and selective serotonin
reuptake inhibitors (SSRIs, e.g., 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.
The pharmacokinetics and clinical tolerability of ascending single doses of BNC210 in healthy volunteers
Protocol Abbreviated Name:
To determine the general clinical tolerability of ascending single doses of BNC210 and to determine the pharmacokinetics
To determine the effects of BNC210 on Bond and Lader visual analogue scales (accepted psychometric methodology by which
patients record their perception of their current state), rating neurological and psychiatric symptoms.
To identify a dose range to be used in subsequent trials
Method: The trial will follow a double-blind placebo-controlled ascending single dose design in healthy volunteers. It is
planned that there will be up to 7 cohorts of four participants each (28 participants in total). The number of
participants per cohort may be increased if additional safety data is required. The drug will be given orally as a