MELBOURNE, Australia,
April 20, 2015 /PRNewswire/ --
Bionomics Limited (ASX: BNO, OTCQX: BNOEF) , a
biopharmaceutical company focused on the discovery and development
of innovative therapeutics for the treatment of cancer and diseases
of the central nervous system, today announced the initiation of a
Phase II clinical study of BNC210, the Company's drug candidate in
development for the treatment of anxiety and depression.
The study will use functional magnetic resonance imaging (fMRI)
to assess the effects of BNC210 on brain activity in patients
suffering from anxiety.
"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," said Dr.
Deborah Rathjen, Bionomics' CEO and
Managing Director.
"Currently, there is a large unmet medical need for fast-acting
anxiolytic agents that lack the side effects observed with existing
treatments, which include sedation and addiction, as well as
negative side effects on memory and body movement. Bionomics'
commitment to the rapid development of BNC210 is indicative of its
significant potential as an improved therapeutic for the treatment
of anxiety.
The double-blinded, placebo and lorazepam-controlled, four-way
crossover single-centre Phase II study (BNC210.006) will be
conducted in 24 patients with untreated Generalised Anxiety
Disorder (GAD). Patients will be randomized to receive one of two
doses of BNC210 (300mg or 2000mg) or one of two controls, placebo
or 1.5mg Lorazepam. The study will evaluate the capacity of BNC210
to engage brain systems relevant to anxiety. The endpoints include
both significant changes in cerebral perfusion and in task-related
brain activity using the emotional faces task during fMRI. The
study is being conducted by Principal Investigator,
Professor Allan Young, at The
Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at
King's College in London.
The clinical phase of the study is expected to be completed by
Q2 2016 with results due in Q3 2016.
Bionomics is also conducting an ongoing Phase Ib multiple
ascending dose study (BNC210.005) of BNC210 in healthy human male
volunteers. This study is examining the safety and tolerability of
multiple doses of BNC210, after repeat dosing for eight days, with
secondary endpoints investigating the pharmacokinetic and
pharmacodynamic profile of BNC210 and its effect on cognitive
functions.
Clinical Trial Appendix
STUDY
REFERENCE
|
BNC210.006
|
STUDY
TITLE
|
A randomised,
double-blinded, placebo and lorazepam-controlled, four-way
crossover, Phase II study to evaluate the effects of single oral
administration of BNC210 on brain activity changes captured by
functional magnetic resonance imaging in adults with Generalised
Anxiety Disorder (GAD).
|
PRIMARY
OBJECTIVES
|
Primary
objectives:
(A) To
determine whether BNC210 causes significant changes in cerebral
perfusion using Arterial Spin Labelling in the resting
state.
(B) To
determine whether BNC210 causes significant changes in task-related
brain activity using the emotional faces task during functional
magnetic resonance imaging (fMRI).
|
SECONDARY &
EXPLORATORY
OBJECTIVES
|
Secondary
objectives:
- To determine
the effect of BNC210 on defensive behaviour.
- To determine
whether BNC210 alters affective self-report in
a way that is
consistent with reduced anxiety.
- To contribute
safety and tolerability information on BNC210.
Exploratory
objective
To determine the
correlation between BNC210-related brain activity changes and
affective self-report.
|
BLINDING
STATUS
|
Double-blinded
|
TREATMENT
METHOD
|
Randomised, four-way
crossover, with the effects of two dose levels of BNC210 being
compared to those of placebo, and 1.5 mg lorazepam used as a
positive control.
The lower BNC210 dose
will be 300 mg. The upper dose will be
2000 mg.
|
TRIAL SUBJECT
NUMBER
|
A sufficient number
of subjects will be enrolled to allow 24 completing
subjects.
|
CONTROL
GROUP
|
Placebo and 1.5mg
Lorezepam Positive Control
|
SUBJECT SELECTION
CRITERIA
|
Male or female
volunteers who are un-medicated but meet the criteria for
Generalised Anxiety Disorder
|
TRIAL
LOCATION
|
The Institute of
Psychiatry, Psychology & Neuroscience, King's
College, London
|
EXPECTED
DURATION
|
Clinical portion to
be completed in approximately 12 months.
|
ADDITIONAL
INFORMATION
|
Pharmacodynamic
evaluation
Brain activity will
be assessed by fMRI under resting condition where functional
connectivity and Continuous Arterial Spin Labelling as a measure of
cerebral blood flow will be collected. Functional fMRI will also be
used during different tasks: an emotional faces task and a
behavioural task (Joystick Operated Runaway Task). The Spielberger
State-Trait Anxiety inventory and a subjective scale assessment
will also be used as outcome measures.
|
CLINICAL TRIAL
HISTORY
|
BNC210 has been
evaluated at single doses in 6 clinical trials and 154 subjects to
date
1. BNC210.001: Single
Ascending Doses Study - Australia
2. BNC210.002: Fed and Fasted
Study - Australia
3. BNC210.003: Lorazepam
Comparison and EEG Study,
cognition as
primary end point - France
4. BNC210.004: CCK Challenge
- France
5. Single Ascending Doses
Study – USA
6. BNC210.005: Multiple
Ascending Dose Study - France
|
FOR FURTHER INFORMATION PLEASE CONTACT:
Bionomics
Limited
|
Monsoon
Communications
|
Stern
IR
|
Dr Deborah
Rathjen
|
Rudi
Michelson
|
Beth
DelGiacco
|
CEO & Managing
Director
|
+613 9620 3333
|
+1 212 360 1200
|
+618 8354 6101
/ 0418 160
425
|
rudim@monsoon.com.au
|
beth@sternir.com
|
drathjen@bionomics.com.au
|
|
|
About BNC210
BNC210 is a first-in-class compound for the treatment of anxiety
that lacks the side effect profile of current therapies such as
benzodiazepines, selective serotonin reuptake inhibitors and
serotonin norepinephrine reuptake inhibitors. BNC210 works by
negative allosteric modulation of the alpha 7 nicotinic
acetylcholine receptor which is key target for anxiety. To date,
BNC210 has been evaluated at single doses in six clinical trials
with 154 subjects.
About Bionomics Limited
Bionomics (ASX: BNO) is biopharmaceutical company which
discovers and develops innovative therapeutics for cancer and
diseases of the central nervous system. Bionomics has small
molecule product development programs in the areas of cancer,
anxiety, memory loss and pain. Its oncology approach includes
cancer stem cell therapeutics.
Bionomics' discovery and development activities are driven by
its four proprietary technology platforms: MultiCore®, a diversity
orientated chemistry platform for the discovery of small molecule
drugs; ionX® , a set of novel technologies for the identification
of drugs targeting ion channels for diseases of the central nervous
system; Angene®, a drug discovery platform which incorporates a
variety of genomics tools to identify and validate novel
angiogenesis targets (involved in the formation of new blood
vessels); and CSC Rx Discovery™, which identifies antibody
and small molecule therapeutics that inhibit the growth of cancer
stem cells. These platforms drive Bionomics' pipeline and underpin
its established business strategy of securing partners for its key
compounds. Bionomics partners include Merck & Co.
www.bionomics.com.au
Factors Affecting Future Performance
This announcement contains "forward-looking" statements
within the meaning of the United
States' Private Securities Litigation Reform Act of 1995.
Any statements contained in this presentation that relate to
prospective events or developments, including, without limitation,
statements made regarding Bionomics' development candidates BNC105,
BNC210, BNC101 and BNC420, our acquisitions of Eclipse Therapeutics
and Prestwick Chemicals and ability to develop products from their
platforms, its licensing deals with Merck & Co, drug discovery
programs and pending patent applications are deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "projects," "forecasts," "will"
and similar expressions are intended to identify forward-looking
statements.
There are a number of important factors that could cause
actual results or events to differ materially from those indicated
by these forward-looking statements, including risks related to our
available funds or existing funding arrangements, a downturn in our
customers' markets, our failure to introduce new products or
technologies in a timely manner, regulatory changes, risks related
to our international operations, our inability to integrate
acquired businesses and technologies into our existing business and
to our competitive advantages, as well as other factors. Results of
studies performed on competitors products may vary from those
reported when tested in different settings.
Subject to the requirements of any applicable legislation or
the listing rules of any stock exchange on which our securities are
quoted, we disclaim any intention or obligation to update any
forward-looking statements as a result of developments occurring
after the date of this presentation.
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SOURCE Bionomics Limited