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news.Bionomics Limited has initiated a second Phase I clinical trial with its anti-anxiety compound BNC210, to determine whether administration of BNC210 with food will alter blood levels of the drug. The trial, expected to be completed in June, is an important lead-in to Phase Ib clinical trials which are expected to commence shortly thereafter.
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Pharmacokinetic data from the initial Phase I trial of BNC210 reported on March 3, 2010 indicated that a plateau of absorption of BNC210 was observed at doses between 600mg and 1200mg. Once the effect of food intake on BNC210 levels in blood is determined, doses for an expanded clinical evaluation of BNC210 will be selected.
Reportedly, an assessment of the levels of serum cortisol will also be undertaken as part of this trial to further assess its potential as a marker of the central nervous system (CNS) effects of BNC210. This follows on from the initial findings in the first clinical trial of BNC210, in which subjects receiving BNC210 showed lower levels of cortisol.
Additionally, the Phase Ib clinical trial is anticipated to commence shortly after completion of this clinical study. The expanded testing of BNC210 will include evaluating BNC210 effects in a setting involving the induction of anxiety in healthy subjects and also evaluation of BNC210 effects on the brain using electroencephalograph (EEG) measurements.
The trial will continue to look at whether side-effects such as sedation or memory impairment, are associated with the administration of BNC210, said Bionomics.
The first Phase I clinical trial of BNC210 indicated that BNC210 was extremely well tolerated at high doses and free of side-effects. These findings, if sustained, will be an important differentiator of BNC210 from many current treatments on the market for anxiety and depression.
Deborah Rathjen, managing director and CEO of Bionomics, said: “As many orally administered drugs are taken either with food or following a meal, it is important to determine early in drug development how food intake affects blood levels of the drug. Bionomics is able to quickly and cost-effectively undertake this trial to pharmaceutical industry standards and, in doing so, will add value to the licensing package for BNC210.”