Ironwood Starts Phase I Trial of Anti-Anxiety Drug in US
Bionomics Limited has been advised by its licensee Ironwood Pharmaceuticals (NASDAQ: IRWD) that, following the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) last month, the planned Phase I clinical trial of the investigational anti-anxiety drug candidate IW-2143 (BNC210) has begun in the US.
The trial is designed to assess the safety and pharmacokinetics of IW-2143 in healthy volunteers, using single and multi-dose administration.
"This is the first US clinical trial of IW-2143 and this news is welcomed by Bionomics as a strong signal of the progress being made by Ironwood in moving ahead with the study of IW-2143," said CEO and Managing Director of Bionomics Dr Deborah Rathjen. "As this trial progresses it is anticipated that a US$2 million milestone payment to Bionomics by Ironwood will be triggered."
Ironwood is responsible for developing and, if approved, commercialising IW-2143 and related compounds, including paying for the costs of clinical development.
In the US, anxiety disorders affect approximately 40 million Americans each year and while there are therapies available, there remains significant unmet need.
About IW-2143 (BNC210)
IW-2143 is a small molecule discovered by Bionomics through a targeted