Australia-based Bionomics has revealed that further data analysis of its phase two post-traumatic stress disorder (PTSD) trial indicated the potential for significant patient benefit when drug exposure is adequate, it was reported yesterday.

Additional work conducted on a drug exposure-response analysis indicated a statistically significant response of BNC210 in treatment of PTSD symptoms, as measured by Clinician-Administered PTSD Scale (CAPS-5) at 12 weeks. Presently, the product is in phase two trial to treat agitation and is a negative allosteric modulator of the alpha-7 (alpha-7) nicotinic acetylcholine receptor.

International pharmacometrics consulting firm, Pharmetheus, conducted an additional data analysis, which indicated a statistically significant response when drug exposure versus response was measured in the phase two trial or Restore trial. According to the company, the analysis indicated a decrease in total PTSD symptoms as measured by total CAPS-5, the endpoint mandated by the US Food & Drug Administration (FDA) for PTSD trials. The analysis quantified the level of efficacy of BNC210 on the overall CAPS-5 score linked to exposure (blood levels) of BNC210.

Bionomics is awaiting guidance from the FDA on the next steps for BNC210 for PTSD, including the design of a further trial and whether BNC210 is eligible for fast track designation.