Positive trial results for anti-anxiety drug give Bionomics a stock bump

Adelaide-based Bionomics (ASX:BNO) has announced positive results from two Phase Ib clinical trials for its anti-anxiety drug, BNC210, leading to a bump in its stock price today.

The trials found that BNC210 significantly reduced the symptoms of a panic attack faster than placebo, and also found that BNC210 exhibited less deleterious side effects and propensity for addiction than a competing anti-anxiety drug, Lorazepam.

The first trial saw healthy subjects administered the peptide, CCK-4, which induces panic symptoms as measured on the Panic Symptom Scale (PSS).

Those subjects who exhibited panic symptoms were then administered BNC210 or a placebo.

According to the company, BNC210 was found to reduce both the total symptoms and the intensity of symptoms in subjects when measured 10 minutes after the induction of a panic attack.

There was also a strong, positive trend on the emotional stability of subjects suffering a panic attack which was associated with BNC210 treatment.

BNC210 treated subjects returned to normal emotional status within 10 minutes of the administration of CCK-4 compared to 60 minutes on placebo. This trend correlated with the statistically significant reduction in panic symptoms by BNC210.

The second trial compared BNC210 with Lorazepam, a Valium-like anti-anxiety drug, on measures of attention, memory, co-ordination, addiction and sedation. This trial also compared the effects of BNC210 and Lorazepam on the brain using electro-encephalography (EEG).

The trial results confirmed the lack of debilitating side-effects of BNC210 relative to Lorazepam. While Lorazepam adversely affected attention, co-ordination and memory, BNC210 showed no evidence of these side-effects.

Lorazepam also induced sedation as measured by the Karolinska Sleepiness Scale and showed evidence of addiction. Testing of the same subjects following administration of BNC210 showed no evidence of sedation or indicators of addiction.

The EEG data showed for the first time BNC210-related changes in human brain activity indicative of efficacy.

According to Bionomics, the changes in brain activity induced by BNC210 were clearly differentiated from those observed following treatment of subjects with Lorazepam, particularly in activity associated with sedation suggesting that BNC210 activity occurs in the absence of sedation.

“The data are very encouraging and point to BNC210 reducing anxiety in a manner that is potentially better for patients than current treatments,” said Professor Paul Fitzgerald of the Monash Alfred Psychiatry Research Centre, Alfred Hospital and Monash University School of Psychology and Psychiatry, commenting on the clinical trial results.

“The EEG data indicates that BNC210 gets into the brain and exerts a more subtle and specific effect than Lorazepam. In addition, subjects recovered more quickly from a CCK-induced panic attack returning to a normal emotional state after 10 minutes when receiving BNC210. On placebo the subjects took around an hour to return to a normal emotional state after the panic attack.”

Bionomics plans to release the full date from the trials at a major international conferences later this year.

“I am delighted that we saw data from human trials consistent with data from our animal studies in that BNC210 clearly lacks the side-effects of sedation, memory impairment and reduction of co-ordination shown by drugs of the benzodiazepine class,” said Dr Sue O’Connor, BNC210 Project Leader.

“We are thrilled to report the positive results of both BNC210 clinical trials,” said Bionomics CEO and Managing Director Dr Deborah Rathjen. “The results have exceeded our expectations.

“Anxiety is a common debilitating condition that affects 19 million patients in the US and anxiety drugs have an estimated worldwide market of up to US$12 billion per annum.

“Blockbuster drugs that treat anxiety include Valium, Prozac and Effexor. 2009 worldwide sales of Effexor alone were US$3.25 billion. These drugs are not ideal and BNC210 represents a next generation treatment for anxiety which stands out as free of the serious side-effects.

Bionomics shares saw heavy trading this morning, jumping from an opening price of 43.5 to 48c around midday, a 10% increase.