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news.Bionomics has announced that further data analysis of its phase 2 post traumatic stress disorder (PTSD) trial demonstrated the potential for significant patient benefit when drug exposure is adequate.
Image: Bionomics’ BNC21 has showed significant effect in phase 2 post traumatic stress disorder trial. Photo: courtesy of everydayplus / FreeDigitalPhotos.net.
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Additional work conducted on a drug exposure-response analysis showed a statistically significant response of BNC210 in treatment of PTSD symptoms, as measured by Clinician-Administered PTSD Scale (CAPS-5) at 12 weeks.
The BNC210, which is currently in phase 2 trial to treat agitation, is a negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor.
International pharmacometrics consulting firm Pharmetheus carried out an additional data analysis, which demonstrated a statistically significant response when drug exposure versus response was measured in the phase 2 trial or Restore trial.
According to the company, the analysis showed reduction 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 now expecting FDA guidance on the next steps for BNC210 for PTSD, including the design of a further trial and whether BNC210 is eligible for fast track designation.
The Restore is a randomized, double-blinded and placebo-controlled phase 2 clinical trial, which recruited 193 adult patients diagnosed with PTSD across 20 sites in the US and six sites in Australia.
The trial’s primary endpoint was a decrease in PTSD symptoms between placebo and BNC210 treatment groups as measured by the CAPS-5 at 12 weeks.
Bionomics executive chairman Dr Errol De Souza said: “Bionomics had a solid scientific rationale for evaluating BNC210 in PTSD, based on its mechanism of action, and this has been borne out by this further analysis. At the time of the topline data announcement of 2 October 2018, the results of the complex and time-consuming drug exposure analyses were not available and could not have readily been foreseen.
“The results of the further analysis are meaningful for future development of BNC210 and they support its continued development for PTSD, as well as other indications, and our ongoing partnering activities.”
