Bionomics (ASX: BNO) is an Australian based international biotechnology company focused on the discovery and development of innovative small molecule therapeutics forcancer, diseases of the central nervous system (“CNS”) and immune disorders.
The company has generated multiple drug candidates and targets in the therapeutic areas of cancer, anxiety, multiple sclerosis and epilepsy. The company has a strong out-license record in conjunction with its in-house development program which has seen two highly promising drugs enter clinical trials in the past two years.
Bionomics presents anti-anxiety compound data at Amsterdam forum
International drug discovery and development company Bionomics (ASX: BNO) has announced today the presentation of preclinical and clinical data for its anti-anxiety compound BNC210 at the annual European College of Neuropsychopharmacology (ECNP) conference in Amsterdam.
A clinical program is ongoing for the treatment of anxiety disorders based on BNC2I0 which exhibits strong anxiolytic activity without side effects in preclinical models. The compound offers blockbuster potential if successfully developed.
The data presented demonstrates preclinical and clinical attributes of BNC210 that provide further support for its development for the treatment of anxiety and depression.
BNC210 is considered more effective than Diazepam in reducing anxiety in a rat model which mimics panic attacks in humans and lacks sedative side effects in the model.
In addition, BNC210 is safe and well tolerated up to a dose of 2000mg in humans and a single oral dose results in higher drug exposure levels than those required for efficacy in preclinical models and is maximal when taken after food.
Deborah Rathjen, CEO & managing director, said she is excited that BNC210 exhibits such potent activity in this preclinical model of panic without displaying sedation which is one of the key side-effects of currently marketed treatments for anxiety.
This new data builds on an already impressive body of evidence pointing to the efficacy of BNC210 in a wide range of animal models.
“Based on the results of this study, it is reasonable to suggest that BNC210 may be of therapeutic benefit for panic disorders and other forms of acute anxiety in addition to general anxiety disorder or more chronic forms of anxiety as well as depression” she said.
The first poster presented at the conference outlines the performance of BNC210 in a rat model of chemically-induced panic. It is well documented that the neurotransmitter, cholecystokinin (CCK), provokes panic attacks in man and provides a model for assessing the efficacy of compounds with the potential to treat anxiety.
Diazepam, which is prescribed for the treatment of anxiety and panic disorder, is known to be active in CCK challenge studies. When the two drugs are compared in CCK-treated rats, BNC210 reduced anxiety in a dose dependent manner without sedation, whereas Diazepam produced clear signs of sedation.
In the second poster Bionomics presented extensive data on the pharmacokinetics, clinical safety and tolerability of increasing single doses of BNC210 in healthy volunteers, pre and post food intake.
On June 21, Bionomics announced it had successfully established a four-fold increase in blood drug levels following food intake.
The therapeutic window is markedly increased when the drug is given with food. Drug exposure reached a plateau at a 600mg dose in fasted subjects, whereas, when BNC210 was given following a meal, the pharmacokinetics of BNC210 appeared approximately linear up to the highest dose (2000mg).
The blood levels observed following a single oral dose of BNC210 were found to exceed the plasma exposure required for efficacy in preclinical models of anxiety and depression.
In addition the drug was well tolerated up to the highest dose tested. BNC210 is about to enter the next stage of clinical development with two Phase Ib clinical
trials anticipated to commence shortly.
