Australia-based Bionomics has reported positive data from additional analysis of the Phase II RESTORE trial that evaluated its BNC210 in post-traumatic stress disorder (PTSD).
BNC210 is a negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor.
The pharmacometric analysis quantified the efficacy level of BNC210 on the overall CAPS-5 score related to exposure (blood levels) of the drug candidate.
Analysis was conducted in Sweden by Pharmetheus and demonstrated a statistically significant response when drug exposure was compared to response.
The data also showed a decrease in total PTSD symptoms as measured using total CAPS-5 endpoint.
Bionomics executive chairman 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.
“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.”
The randomised, double-blinded, placebo-controlled RESTORE trial involved 193 adults with PTSD at 20 sites in the US and six centres in Australia. Primary endpoint of the trial was reduction in PTSD at 12 weeks.
Bionomics has determined an improved solid dose formulation of BNC210 that is believed to have the potential to overcome the ‘food effect’ and the consequent variable blood observed with administration of a liquid formulation.
The company is planning to use the solid dose formulation in any future PTSD trials.
It also intends to seek US Food and Drug Administration (FDA) guidance for BNC210 assessment in a further trial and its eligibility for fast track designation.
Bionomics will also perform exposure-response analyses of BNC210’s Phase II exploratory trial being conducted for the treatment of agitation in elderly patients.