Australian biopharmaceutical firm Bionomics has reported positive data from the completed Phase I trial of BNC210, an orally administered negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor (alpha-7 receptor), being developed to treat anxiety and depression.
Results from the multiple ascending dose, placebo controlled Phase I trial showed that BNC210 was safe and well-tolerated, and consistent with its mechanism of action at the a7 receptor.
The data also showed that BNC210 significantly reduced the effect of nicotine as measured by electrocephalogram (EEG).
Biotrial Research and Development senior director Dr Philippe Danjou said: "BNC210 has shown an encouraging safety and tolerability profile and the demonstration that BNC210 modulates nicotine-dependent changes as measured by EEG provides evidence of target engagement.
"These data support the continued development of BNC210 in this area of great unmet medical need."
A total of 54 healthy volunteers were enrolled and dosed in the trial for eight consecutive days, with 42 subjects receiving BNC210 (300mg - 2,000mg total dose per day) and 12 placebo.
In addition to 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.
The company noted 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 EEG.
The company said 13 responded to nicotine in a dose dependent manner out of the 30 subjects administered with nicotine prior to administration of either BNC210 or placebo.
Bionomics CEO and managing director Dr Deborah Rathjen said: "BNC210 exemplifies Bionomics' mission of discovering and developing proprietary, first in class drug candidates with the potential to significantly benefit patients.
"We believe BNC210 may offer differentiation from currently-approved drugs for the treatment of anxiety and depression."