Clinically significant anxiety disorders represent one of the most widespread health problems in the developed world. Historically, treatments for anxiety have been some of the most commercially successful products in the pharmaceutical industry. Annual sales of treatments for anxiety and related conditions are approximately US$12 billion.
However, current treatments suffer from serious side effects including sedation, memory loss and addiction. Others are unsatisfactory for patients due to slow onset of action (weeks), or sexual dysfunction side-effects.
Bionomics has discovered a novel compound BNC210 that offers dramatic competitive advantages over existing treatments. While providing excellent relief of anxiety in animal models, it shows no evidence of sedation, memory impairment or tendency to addiction. BNC210 has a rapid onset of action and is suitable for oral dosing.
BNC210 acts by a completely novel mechanism of action distinct from known drugs and is therefore first a new class of novel anxiety drugs offering dramatically improved patient benefits.
Two Phase Ib trials of BNC210 were initiated in France in October 2010 and results were announced in March 2011.
The first trial evaluated the effect of BNC210 on panic symptoms induced by pharmacological means in 59 healthy volunteers. BNC210 reduced the symptoms and intensity of symptoms when measured 10 minutes after the induction of the panic attacks, and faster than placebo. There was a strong, positive trend on the emotional stability of subjects suffering panic attacks, which was associated with BNC210 treatment.
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 electroencephalography (EEG). 24 subjects were enrolled in the trial with 21 subjects evaluated.
An important finding was that EEG data showed for the first time BNC210-related changes in human brain activity indicative of efficacy. 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.
In addition, 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.
In short BNC210 significantly reduced panic symptoms and faster than placebo and clearly outperformed comparator Lorazepam in tests measuring attention, memory, co-ordination, sedation and addiction. It has an excellent safety profile.
Together these results confirm BNC210's potential as a next generation treatment for anxiety which stands out as free of the serious side-effects.