Bionomics Limited, a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of cancer and diseases of the central nervous system, announced the initiation of a phase II clinical study of BNC210, the company's drug candidate in development for the treatment of anxiety and depression.
The study will use functional magnetic resonance imaging (fMRI) to assess the effects of BNC210 on brain activity in patients suffering from anxiety.
"BNC210 has the potential to significantly improve the lives of anxiety sufferers, and we believe that with effective management of anxiety there is the potential to reduce the huge impact of the disease on societal and healthcare resources," said Dr. Deborah Rathjen, Bionomics' CEO and managing director.
"Currently, there is a large unmet medical need for fast-acting anxiolytic agents that lack the side effects observed with existing treatments, which include sedation and addiction, as well as negative side effects on memory and body movement. Bionomics' commitment to the rapid development of BNC210 is indicative of its significant potential as an improved therapeutic for the treatment of anxiety,” said Dr Rathjen.
The double-blinded, placebo and lorazepam-controlled, four-way crossover single-centre phase II study (BNC210.006) will be conducted in 24 patients with untreated Generalised Anxiety Disorder (GAD).
Patients will be randomized to receive one of two doses of BNC210 (300mg or 2000mg) or one of two controls, placebo or 1.5mg Lorazepam. The study will evaluate the capacity of BNC210 to engage brain systems relevant to anxiety. The endpoints include both significant changes in cerebral perfusion and in task-related brain activity using the emotional faces task during fMRI. The study is being conducted by principal investigator, professor Allan Young, at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College in London.
The clinical phase of the study is expected to be completed by Q2 2016 with results due in Q3 2016.
Bionomics is also conducting an ongoing phase Ib multiple ascending dose study (BNC210.005) of BNC210 in healthy human male volunteers. This study is examining the safety and tolerability of multiple doses of BNC210, after repeat dosing for eight days, with secondary endpoints investigating the pharmacokinetic and pharmacodynamic profile of BNC210 and its effect on cognitive functions.
BNC210 is a first-in-class compound for the treatment of anxiety that lacks the side effect profile of current therapies such as benzodiazepines, selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors. BNC210 works by negative allosteric modulation of the alpha 7 nicotinic acetylcholine receptor which is key target for anxiety. To date, BNC210 has been evaluated at single doses in six clinical trials with 154 subjects.