Bionomics announces positive results in phase Ia trial of anti-stress drug

Bionomics Limited (ASX: BNO) today announced the final results of its Phase Ia clinical trial of BNC210.

Dosing of healthy male volunteers in stage 2 of the Phase Ia trial, which was conducted at the Pain and Anaesthesia Research Clinic (PARC) within the Royal Adelaide Hospital, was completed on schedule at the end of last year.

The primary objectives of the trial, to evaluate the safety, tolerability and the pharmacokinetics of BNC210 were met when stage 1 trial results were reported on 27 October 2009. Stage 1 of the trial evaluated a dose range of 5mg to 1200mg.

Evaluation of the safety and tolerability of BNC210 in stage 2 of the trial, in which subjects received either 2000mg of BNC210 or placebo, confirmed that BNC210 is safe and well tolerated at high dose levels.

In addition to safety and tolerability, stage 2 of the trial also involved an evaluation of blood cortisol levels. This evaluation showed that lower cortisol levels were observed in subjects receiving BNC210 compared to placebo. As anxiety and stress lead to an elevation of cortisol, the observed change following BNC210 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 2 of the trial also enabled an extension of pharmacokinetic data which indicated that a plateau of absorption of BNC210 was observed at doses between 600mg and 1200mg.

The Principal Investigator on the trial Paul Rolan, Professor of Clinical Pharmacology at the University of Adelaide and a co-founder of PARC, commented: "The first clinical testing of BNC210 in man has made important progress and under the conditions of this trial BNC210 has been shown to be safe and well tolerated. The most common reported side-effects which are possibly related to the drug were fatigue and headache, however these were quite mild."

Professor Rolan further commented: “The second stage of the Phase Ia trial has yielded interesting data on blood cortisol levels. Anxiety and stress lead to an elevation of cortisol and subjects treated with BNC210 showed lower levels of cortisol in their blood. This finding, which will require further confirmation, may enable cortisol and potentially other neuroendocrine hormones to be used as biomarkers of BNC210 activity."

Dr Deborah Rathjen CEO & Managing Director of Bionomics said: “We are very pleased with the outcome of this trial as we now have de-risked the BNC210 program with the data coming out of the study confirming that BNC210 is safe and has a pharmacokinetic profile which supports once a day administration. This trial has also given us an insight into biomarkers indicative of anxiety such as cortisol which will be followed up in the planned Phase Ib clinical trial and which provide valuable information for the BNC210 licensing package."

BNC210 is being developed for the treatment of anxiety and co-morbid depression.

Anxiety is a common debilitating condition that affects 40 million patients over the age of 18 years in the US alone, and has an estimated market value of up to US$15 billion worldwide.

Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, feelings of guilt or low self esteem, disturbed sleep or appetite, low energy and poor concentration. Each year an estimated 6% of adult Australians are affected by a depressive illness. According to the World Health Organisation, depression affects an estimated 121 million people worldwide.

The global antidepressant market reached sales of almost US$11 billion in 2008, with drugs such as Cymbalta (US$2.7B), Effexor, which is also used for the treatment of generalised anxiety disorder (US$3.9B), and Lexapro (US$2.29B) being the primary drug treatments.