Bionomics (ASX:BNO) has announced it will proceed with evaluating its lead clinical compound, BNC210, for the treatment of acute treatment of Social Anxiety Disorder (SAD) while progressing toward the start of its planned Phase 2b trial in Post-Traumatic Stress Disorder (PTSD).
BNC210 is a novel, first-in-class, negative allosteric modulator of the α7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders. In November 2019 it was granted Fast Track designation by the US FDA for the treatment of PTSD.
The company said a previous successful Phase 2a study in GAD patients demonstrated that acute administration of the liquid suspension formulation of BNC210 had significant anti-anxiety effects as measured in brain imaging and behavioural studies similar to benzodiazepines but without evidence for sedation or addictive potential.
"The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD," said the company, adding, "A new solid dose tablet formulation of BNC210 has been successfully developed, showing much improved and rapid absorption over the previous liquid suspension formulation, and will be used for the Phase 2 efficacy clinical trials in SAD and PTSD."
"Anxiety disorders are a significant burden for our communities and approximately 17 million American adults suffer from Social Anxiety Disorder. The new spray dry oral solid dose tablet formulation of BNC210 which is rapidly absorbed and reaches maximal concentrations in the blood in approximately one hour may be ideal for the acute treatment of SAD patients to better cope with anticipated anxiety-provoking social interactions and other public settings.
"We look forward to providing details on the Phase 2 SAD clinical trial design and timelines over the next quarter while we remain on track for initiation of our Phase 2b PTSD trial in mid-2021,” said Bionomics executive chairman Dr Errol De Souza.