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
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
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“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.