The Food and Drug Administration (FDA) has granted Fast Track designation to BNC210 (Bionomics Limited) for the treatment of post-traumatic stress disorder (PTSD) and other trauma-related and stressor-related disorders.
BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor being developed for the treatment of PTSD, anxiety disorders, comorbid anxiety and depression. The Company notes that unlike other anti-anxiety medications (ie, benzodiazepines), the investigational drug does not cause sedation, memory or motor impairment, and is not addictive.
The designation was based on the 12-week, double-blind, placebo-controlled, phase 2 RESTORE study that evaluated the effects of BNC210 vs placebo on the symptoms of PTSD in 193 patients, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). While results of the study showed BNC210 did not significantly improve symptoms, a dose-response relationship predicted to meet the primary end point has been established based on the trial data. The Company plans to initiate a phase 2b trial to further evaluate a solid dose formulation of BNC210 for the treatment of PTSD.
“We are pleased with the progress that we have made over the last year in getting BNC210 back on track by carrying out extensive pharmacometric analysis and 2 pharmacokinetic studies demonstrating that the target blood levels predictive of efficacy in the treatment of PTSD can be achieved with our new solid dose formulation. We look forward to taking advantage of the Fast Track designation and working closely with FDA in the design and initiation of the next phase 2b study in PTSD patients,” said Dr Errol De Souza, Executive Chairman of Bionomics.
For more information visit bionomics.com.au.