Phase 1 clinical trials have begun for Bionomics' (ASX:BNO) anticipated anti anxiety drug, BNC210.
One of the major benefits of the profile of BNC210 is 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.
The potential market for anxiety treatments is around US$15 billion in size and offers tantalising potential for a company like Bionomics that can crack the side-effects and slow acting nature of current anxiety drugs.
Current treatments do not service patients very effectively said Dr Deborah Rathjen, CEO and Managing Director of Bionomics. "BNC210 may represent an advance in the treatment of both acute and chronic forms of anxiety.”
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) as well as other side effects.
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).
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