Bionomics gets approval for BNC210 trial

Bionomics (ASX:BNO) has secured approval for a new human trial of anti-anxiety and depression candidate BNC210, and expects the trial to commence before the end of the year.

The phase Ib dose-escalation study will be conducted in France by Biotrial International. The trial in healthy volunteers is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug.

Four groups will receive one of each of four oral doses of BNC210 or a placebo twice daily for eight days. Pharmacodynamic assessments measuring cognitive parameters will include choice reaction time, digit vigilance and a learning memory test.

The company also plans to apply to commence a phase II trial in anxiety patients, expected to commence in the first quarter. Bionomics has lined up US$10 million in funding for the drug’s continued development, to be paid back over a 30-month period.

Bionomics entered a deal with Ironwood Pharmaceuticals covering development of the compound in January 2012. At the time, the deal was expected to be worth up to US$345 million ($399.5 million).

But the companies have since mutually agreed to terminate this arrangement, with Bionomics reassuming the sole worldwide rights to develop and commercialise the drug.

The company has announced an intent to progress the candidates clinical development further before seeking any further partnering deals.

“Bionomics is in a strong position to dedicate the necessary internal resources and has secured non-dilutive funding specifically for the purpose of progressing BNC210 into the next stage of development,” Bionomics CEO Dr Deborah Rathjen said.

“Much has been achieved in the past two years in building towards Phase II, including formulation and an extensive toxicology program.”

Bionomics (ASX:BNO) shares were trading 0.9% higher at $0.56 as of around 12.30 pm on Tuesday.