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news.Bionomics has concluded the second placebo controlled and blinded trial Phase I clinical trial of its anti-anxiety compound BNC210. The aim of this trial was to determine whether administration of BNC210 with food alters blood levels of the drug.
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Bionomics’ Phase I study was conducted in healthy male volunteers at the pain and anaesthesia research clinic (PARC) within the Royal Adelaide Hospital and Paul Rolan was the principal investigator for the study.
Bionomics said that one of the secondary objectives of this trial was the evaluation of potential biomarkers showing BNC210 effects. These include the determination of stress hormone levels. These tests are currently in progress with data anticipated to be available next quarter.
Bionomics is expecting to initiate two Phase Ib clinical trials of BNC210 in next quarter. The first of the new trials is expected to assess BNC210 effects when anxiety is induced in healthy subjects whilst the second trial is expected to assess BNC210 effects on the brain using electroencephalograph (EEG) measurements.
Deborah Rathjen, CEO and managing director of Bionomics, said: “Many common drugs are taken either with food or following a meal. The increased exposure seen when BNC210 is given with food expands the dosing range to be used in its continued development for the treatment of anxiety and depression.
“In particular it has allowed us to identify the doses to be used in the planned Phase Ib studies of BNC210. The data also suggests that lower doses of BNC210 may be effective when the drug is given with food.
“This latest data also confirms the results of the initial Phase I clinical trial of BNC210 which indicated that BNC210 was well tolerated at high doses and free of side-effects.”