Written by S. Bowyer


     Bionomics are now onto human trials of their new compound, BNC210 AKA IW-4132. The company are known for innovative treatments for central nervous system diseases. They also focus on cancer, anxiety, memory loss and pain management.

     BNC210 is an anxiolytic drug that works as a negative allosteric modulator for the a7-nicotinic acetylcholine receptor. In layman's terms, it's a regulator of a body protein, that which is released by the alpha-7 nicotinic receptor. This receptor is found in the spleen, brain, lymph nodes and lymphocytes, and has been connected to brain functions, such as neurocognition, and has great control over our memory, working memory, learning and attention, and Bionomics believe its alteration could relieve the symptoms of anxiety. It backs what neuropsychiatrists hypothesise, that depression might be caused by a faulty neuroendocrine system, caused by prolonged responses to stress. Evidence has suggested that acetylocholine might mediate in these responses including emotional and psychological reactions.

     Phase one trials showed anxiety reduction in animals, while test subjects were not showing typical symptoms associated with anti-anxiety medications prescribed currently. Test models showed no signs of sedation, memory-impairment, addiction to the drug, or body movement issues.

     Phase two clinical trials began in April, 2015, consist of a "double-blinded placebo and Lorazepam controlled four-way crossover single-centre study" on 24 patients with Generalised Anxiety Disorder, meaning patients have high levels of anxiety to many stimuli many times a day. Brain activity is monitored via EEG while patients' anxiety levels are pressed. One such experiment is giving the patients nicotine to look for affective anxiety symptoms. Other investigations include seeking out possible addictive tendencies to BNC210, of which none have been seen so far. The use of Lorazepam, an anti-anxiety medication that is known to affect attention, co-ordination, memory, and can cause sedation and addiction, is being compared to BNC210 to verify effectiveness and symptomatology.

     Current trials are testing with a multiple ascending dose study on healthy human males to assess safety and patients' acceptance of the drug. Some reports have found BNC210 increases potency when taken with food, which could mean lower doses could be used for the same effect, which could ultimately mean less chance of symptoms or toxicity even in extreme cases. The tests will be followed by further examinations to determine the effects of cognitive function while on BNC210.

     “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 significant side-effects,” said Dr. Deborah Rathjen, Bionomics’ CEO and Managing Director.

     “BNC210 has the potential to significantly improve the lives of anxiety sufferers, and we believe that with effective management of anxiety there is the potential to reduce the huge impact of the disease on societal and healthcare resources.”

     “Currently, there is a large unmet medical need for fast-acting anxiolytic agents that lack the side effects observed with existing treatments . .. Bionomics’ commitment to the rapid development of BNC210 is indicative of its significant potential as an improved therapeutic for the treatment of anxiety. "

     Effectiveness of the drug is showing promise. Human models have found quicker relief from panic attacks. Typical recovery time without medication is an hour, but while using BNC210, test subjects have recovered as quickly as ten minutes. This means greater comfort for panic attack sufferers without a prolonged embarrassment and "fight or flight" biological responses, and a lower social impact if attacks occur in public.

     Professor Paul Fitzgerald of the Monash Alfred Psychiatry Research Centre said, "The data are very encouraging and point to BNC210 reducing anxiety in a manner that is potentially better for patients than current treatments. The EEG data indicates that BNC210 gets into the brain and exerts a more subtle and specific effect than Lorazepam."

     BNC210 has been in the pipelines since 2009, when reports came out that testing would begin. However, if successful, the drug will pay for the time invested, sources stating that contracts are worth ove $345 million US dollars. Rathjen said during 2011 that the estimated worldwide market for anti-anxiety drugs is up to US$12 billion per year. Bionomics state they are very happy with the data the trials are showing, their releasing a promising product by 2017 a potential reality.

     “We are thrilled to report the positive results of both BNC210 clinical trials. The results have exceeded our expectations," Rathjen said.

     "BNC210 represents a next generation treatment for anxiety which stands out as free of the serious side-effects." Rathjen says.

     Bionomics aim to complete and release BNC210, before starting trials on new medications they have planned. BNC105, a cancer treatment, aims to shut down the blood supply to solid tumors and starves them; KV1.3 is a future Multiple Sclerosis treatment. Additionally, they aim to look further into the Alpha 7, and research its memory impairment affects, and how that might be connected to Alzheimers and Parkinson's disease. BNC164 was announced in 2014, a treatment for auto-immune diseases such as psoriasis, rheumatoid athritis and eye conditions.

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