Bionomics (ASX:BNO), an Adelaide-based biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer, has reported positive data from the completed Phase 1 multiple ascending dose, placebo controlled clinical trial of BNC210.
BNC210 is an orally administered negative allosteric modulator of the α7 nicotinic acetylcholine receptor (α7 receptor) being developed for the treatment of anxiety and depression.
According to the company, the results showed that BNC210 was safe, well-tolerated and, consistent with its mechanism of action at the α7 receptor, significantly reduced the effect of nicotine as measured by electrocephalogram (EEG).
Dr Philippe Danjou, Senior Director, Research and Development at Biotrial, 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.”
In the study, a total of 54 healthy volunteers were enrolled and dosed for eight consecutive days, with 42 subjects receiving BNC210 (300mg - 2,000mg total dose per day) and 12 placebo.
Study results showed BNC210 was safe and well tolerated at all dose levels, and a maximum tolerated dose was not reached. No subject discontinued due to treatment-emergent adverse events.
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.
"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." Dr Rathjen added.
Investors responded positively to the result, boosting the company's share price by 12.5 per cent.