IND Submission to FDA for IW-2143 (BNC210) Anti-Anxiety Drug Candidate
*Bionomics' licensee Ironwood Pharmaceuticals has submitted an
Investigational New Drug application to the US Food & Drug Administration
*IND is a precursor to proceeding with clinical trials on IW-2143 in the US
ADELAIDE, Australia, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Bionomics Limited
(ASX:BNO) (ADR:BMICY) has been advised by its licensee Ironwood
Pharmaceuticals Inc that an Investigational New Drug (IND) application was
submitted to the US Food and Drug Administration (FDA) for a clinical trial of
anti-anxiety drug candidate IW-2143.
Ironwood intends to initiate Phase I studies with IW-2143 in healthy
volunteers following the filing of the IND by the FDA. The initial Phase I US
trial is designed to further assess IW-2143's pharmacokinetics.
"Ironwood has a strong team that has developed a thorough clinical development
program for IW-2143," said CEO and Managing Director of Bionomics Dr Deborah
Preclinical studies conducted by Bionomics suggest that IW-2143 has
anti‐anxiety activity and promotes neurite outgrowth.
In the US alone, anxiety disorders affect 40 million Americans each year and
while there are therapies available, there remains a significant unmet need.
IW-2143 has the potential to fill a need in this market as an anxiety drug
that may not have the sedation, withdrawal syndrome or memory impairment
reported with other therapies.
About IW-2143 (BNC210)
IW-2143 is a novel small molecule discovered by Bionomics through a targeted
medicinal chemistry program. Data from several preclinical studies indicate
that IW-2143 has anti-anxiety activity and promotes neurite outgrowth in
vitro. In a phase I study that included placebo and lorazepam control arms,
healthy volunteers who took IW-2143 did not appear to have impaired attention.
Electroencephalography (EEG) data gathered on healthy subjects dosed with
IW-2143 in the study provided evidence of a pharmacodynamic effect.
About Bionomics Limited
Bionomics (ASX:BNO) is a leading international biotechnology 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, epilepsy and multiple sclerosis.
BNC105, which is undergoing clinical development for the treatment of cancer,
is based upon the identification of a novel compound that potently and
selectively restricts blood flow within tumours. BNC105 offers blockbuster
potential if successfully developed. A clinical program is also underway for
the treatment of anxiety disorders and depression based on IW-2143(BNC210), a
novel compound which stimulates neurite outgrowth. IW-2143 is partnered with
Bionomics' discovery and development activities are driven by its three
technology platforms: 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). MultiCore® is Bionomics'
proprietary, diversity orientated chemistry platform for the discovery of
small molecule drugs. ionX® is a set of novel technologies for the
identification of drugs targeting ion channels for diseases of the central
nervous system. These platforms underpin Bionomics' established business
strategy and Bionomics is committed to securing partners for its key
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, IW-2143(BNC210), our acquisition of
Eclipse Therapeutics and ability to develop products from their platform, its
licensing deal with Ironwood Pharmaceuticals, 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
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, Ironwood's decisions to
continue or not continue development of IW-2143, 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
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.
CONTACT: FOR FURTHER INFORMATION PLEASE CONTACT:
Dr Deborah Rathjen
CEO & Managing Director
+618 8354 6101 /
0418 160 425
+613 9620 3333
The Trout Group
+1 646 378 2972
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