Updated on 8 November 2012
Ironwood submits IND for anti-anxiety drug on behalf of Bionomics
Singapore: Bionomics has been advised by its licensee Ironwood Pharmaceuticals that an Investigational New Drug (IND) application was submitted to the US 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 Dr Deborah Rathjen, CEO and MD, Bionomics.
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.