European Approval Granted for Two Phase Ib Clinical Trials of Bionomics' BNC210
First trial will evaluate the potential for BNC210 to relieve panic attacks and reduce symptoms of anxiety
Bionomics Limited announced approval from the French Medical Agency AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante) and the Ethics Committee of the Strasbourg Hospital, CPP (Comité de Protection des Personnes), to perform two advanced Phase I clinical trials with BNC210, Bionomics’ compound in development for the treatment of anxiety and depression.
The first of the newly approved clinical studies will examine whether BNC210 reduces panic and anxiety symptoms induced by pharmacological means in healthy volunteers. The peptide CCK-4 will be used to induce symptoms of panic and anxiety. Bionomics has previously reported that BNC210, in a rodent model of CCK induced anxiety, overcomes the effects of CCK. These results were recently presented at a major international conference, the European Congress of Neuropsychopharmacology (ECNP).
The second trial will evaluate the effects of BNC210 on the brain using electro-encephalograph (EEG) and quantitative assessments of memory function. In this trial the effects of BNC210 will be compared with Lorazepam, a drug closely related to Valium, which is known to have the adverse side effect of causing memory impairment.
Both trials will be conducted in France by Forenap Pharma, an International Contract Research Organization (CRO), which has 20 years experience in early drug development and conducting studies into the effects of drugs on the central nervous system. Bionomics’ subsidiary, Neurofit SAS, is the designated sponsor of the trials. Forenap has the capacity to run both clinical studies in parallel and it is anticipated that data from both trials will be available in the first quarter of 2011.
Dr Deborah Rathjen CEO & Managing Director of Bionomics commented “Today’s announcement heralds a major step forward in the development of BNC210 for the treatment of anxiety disorders. Our previous Phase I clinical trials indicated that BNC210 was safe and well tolerated and with no indication, even at high dosage levels, of the side effects found in many currently available drugs used to treat anxiety.
Whilst these new clinical trials will be conducted in healthy volunteers, both studies have been specifically designed to demonstrate the value of BNC210 as an innovative treatment for anxiety and depression”.
Panic disorder is a common type of anxiety disorder experienced by 1.7% of the population. It is currently treated with benzodiazepines such as Valium and Xanax. Forbes.com recently reported that Xanax, the first drug approved for the treatment of panic attacks, is the most prescribed psychiatric drug in the US, with one prescription issued every second in 2009.
“Bionomics’ trials of BNC210 will investigate the potential of BNC210 to relieve symptoms of panic and anxiety. They will also evaluate the brain effects of BNC210 compared to Lorazepam, another benzodiazepine, which is known to impair memory. The potential commercial implications of positive results in these two trials cannot be overstated” Dr Rathjen further commented.
Details of the approved European trials are shown below in the Clinical Appendix following this announcement.
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