Ironwood Pharmaceuticals Inc. has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for a clinical trial of anti-anxiety drug candidate IW-2143.

Ironwood intends to initiate Phase 1 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 Rathjen.

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.

Date: November 7, 2012
Source: Bionomics Ltd.