(MENAFN - ProactiveInvestors - Australia) Bionomics' (ASX: BNO) licensee Ironwood Pharmaceuticals has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial of anti-anxiety drug candidate IW-2143.
This paves the way for Ironwood to begin phase one studies of IW-2143 in healthy volunteers.
Highlighting the market potential of an anti-anxiety drug, annual sales of treatments for anxiety and related conditions are around US12 billion.
Preclinical studies conducted by Bionomics suggest that the drug has antianxiety activity and promotes neurite outgrowth.
In the U.S. 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.
Bionomics is well-funded to continue development of its broad pipeline of products, with over A13 million in cash at the end of the September quarter.
The company is an emerging biotech with global operations in Australia, Europe and the United States.
Bionomics is targeting multi-billion dollar market opportunities in solid tumour oncology, central nervous system, and immune diseases.
The company has a significant partnership with Ironwood Pharmaceuticals for the development of BNC210 for the treatment of anxiety and depression.
The partnership includes up to US345 million in upfront, development (clinical trials) and regulatory milestone payments and royalties on net sales of products incorporating BNC210 (IW-2143).
US13 million is anticipated to January 2014 and Ironwood will fund all clinical trials and other development activities.