IND lodged for Bionomics anxiety compound

Shares in Bionomics (ASX:BNO) climbed nearly 5% after the company revealed licensing partner Ironwood Pharmaceuticals has lodged an Investigational New Drug application with the Food and Drug Administration in the US and has been cleared for a US clinical trial of its anti-anxiety candidate.

The US FDA has approved Ironwood's IND application for the trial of IW-2143, developed by Bionomics as BNC210.

Ironwood in January handed Bionomics a deal worth up to US$345 million ($331.6 million) for licensing rights to the compound, agreeing to fund worldwide commercialisation and development. The deal is the largest ever in Australian biotech for a phase I asset.

The FDA's approval of the IND application marks a major milestone for the product's commercial development.

With the FDA's blessing, Ironwood will now commence phase I trials of the treatment candidate in healthy volunteers. The first trial will concentrate on pharmacokinetics.

IW-2143/BNC-210 is a small molecule shown in preclinical studies to promote anti-anxiety as well as neurite outgrowth in vitro.

Bionomics is also at the trial stage for anti-cancer compound BNC105, and is seeking licensing partners for its Alpha 7 program targeting neurodegenerative conditions including Alzheimers as well as its Kv1.3 Multiple Sclerosis program.

The latter had been in development in partnership with Merck Serono, but this collaboration was called off in June.

Bionomics (ASX:BNO) shares were trading 4.62% higher at 34c at 2.30pm on Monday, with a high of 35c through the day.