Trade Resources Company News Ironwood Submitted IND Application to FDA to Begin IW-2143 Clinical Trial

Ironwood Submitted IND Application to FDA to Begin IW-2143 Clinical Trial

Ironwood Pharmaceuticals, Bionomics' licensee, has submitted an investigational new drug (IND) application to the FDA to begin IW-2143 clinical trial.

The trial will further evaluate pharmacokinetic profile of the anti-anxiety drug candidate in healthy volunteers.

Bionomics CEO and managing director Dr Deborah Rathjen said, "Ironwood has a strong team that has developed a thorough clinical development program for IW-2143."

Data from preclinical studies suggest that IW-2143 exhibits anti-anxiety activity and encourages neurite outgrowth under lab conditions.

Healthy volunteers who took part in a two arm phase I study did not demonstrate impaired attention after receiving IW-2143.

Electroencephalography (EEG) data collected from IW-2143 dosed subjects confirmed the pharmacodynamic effect.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/ironwood-submits-iw-2143-ind-application-to-fda-091112
Contribute Copyright Policy
Ironwood Submits IW-2143 IND Application to FDA