Bionomics Announces Trial Results for Antidepressant Drug

Bionomics has announced the final results of its Phase Ia clinical trial of BNC210. The primary objectives of the trial, to evaluate the safety, tolerability and the pharmacokinetics of the drug were met when stage one trial results were reported on 27 October 2009. Stage one of the trial evaluated a dose range of 5mg to 1200mg.

Evaluation of the safety and tolerability in stage two of the trial, in which subjects received either 2000mg of BNC210 or placebo, confirmed that the drug is safe and well tolerated at high dose levels.

Stage two of the trial also involved an evaluation of blood cortisol levels. This evaluation showed that lower cortisol levels were observed in subjects receiving the drug compared to placebo. As anxiety and stress lead to an elevation of cortisol, the observed change following drug administration is consistent with anxiolytic activity, and suggests that blood levels of this stress related hormone may be useful as a biomarker of BNC210 activity.

Stage two of the trial also enabled an extension of pharmacokinetic data which indicated that a plateau of absorption of the drug was observed at doses between 600mg and 1200mg.