Bionomics’ BNC210 phase 1 trial for anxiety and depression meets primary and secondary endpoints

No adverse effects on cognition or emotional stability and no abuse potential were indicated with BNC210 reducing the effect of nicotine.

The company enrolled 54 healthy volunteers and dosed for eight consecutive days. Of the total patients, 42 received BNC210 and the remaining a placebo.

In addition to the detailed safety evaluations, all the subjects in the trial underwent a standard battery of assessments measuring cognitive parameters.

According to the results, BNC210 was safe and well tolerated at all dose levels, and a maximum tolerated dose was not reached.

Bionomics said that an additional pharmacodynamic test, the nicotine shift assay, was performed in subjects receiving either the highest dose of BNC210 or placebo.

In this test, all non-smoking subjects were administered nicotine by nasal spray with responses measured by electrocephalogram.

The company said 13 responded to nicotine in a dose dependent manner out of the 30 subjects administered with nicotine before administration of either BNC210 or placebo.

Bionomics CEO & managing director Deborah Rathjen said: "We look forward to progressing our current Phase 2 trial in patients with Generalized Anxiety Disorder and to considering other potential indications for BNC210 within the spectrum of anxiety disorders and depression.

"Anxiety and depression have overlapping symptoms and an estimated 40 percent of patients with depression also have anxiety."

BNC210 is an orally administered negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor.

About 14.4% of the Australian population is affected by anxiety and around 40 million people suffer from anxiety disorders in the US. The anxiety market is expected to reach $18.2bn by 2020.