Bionomics initiates BNC210 Phase 1b clinical trial in healthy volunteers

Bionomics LimitedFeb 2 2015

Bionomics Limited (ASX:BNO) has initiated a Phase 1b clinical trial in healthy volunteers of BNC210, the Company's drug candidate in development for the treatment of anxiety and depression.

The trial will be conducted by Biotrial International at its facility in Rennes, France and will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BNC210. This is a randomised, double-blind, placebo-controlled trial and will treat over 50 healthy male volunteers in sequential multiple ascending doses.

Four groups of subjects will be enrolled to receive one of four doses of BNC210 or placebo, twice a day for eight days.

Target engagement by BNC210 will be investigated through the use of a nicotine challenge where the subjects response to nicotine will be monitored by a brain EEG. All subjects on the study will undergo a standard battery of pharmacodynamic assessments.

The primary endpoint of the trial will be the safety and tolerability of BNC210 following multiple administrations with secondary endpoints investigating the pharmacokinetic and pharmacodynamic profile of BNC210 and its effect on cognitive functions and the response to nicotine.

In addition a Phase 2a study for BNC210 in human patients suffering anxiety is planned with the trial anticipated to commence during Q1, 2015 in the UK. These trials mark vital steps in the development of BNC210 and will position it for partnering opportunities.

"We're eager to get back to the clinic with BNC210 and unlock the potential of this compound," said Dr Deborah Rathjen, Bionomics' CEO and Managing Director.

"We expect this to be a pivotal year in its development and given the data thus far are confident it will be another Bionomics drug candidate that will attract the interest of big pharma companies."

Data from this trial is anticipated in Q3, 2015.