Adelaide-based clinical-stage biopharmaceutical company Bionomics (ASX:BNO) has announced the details of an additional data analysis of a phase 2 trial of BNC210 that shows a statistically significant response in the treatment of PTSD symptoms.
The exposure-response analysis of the RESTORE trial was conducted in Sweden by Pharmetheus AB.
The exposure-response analysis uses patient blood levels of the drug, regardless of the administered dose, to relate drug exposure to the response measured in the trial patients.
According to the company, the analysis demonstrated a reduction in total PTSD symptoms as measured by total CAPS-5, the endpoint mandated by the US FDA for PTSD trials.
“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,” said Dr Errol De Souza, executive chairman of Bionomics.
The pharmacometric analysis conducted by Pharmetheus AB, an international pharmacometrics consulting company, was led by Mats O Karlsson, Professor in Pharmacometrics at Uppsala University. The analysis quantified the level of efficacy of BNC210 on the overall CAPS-5 score related to exposure (blood levels) of BNC210.
Professor Karlsson said, “Exposure-response modelling has shown the potential for BNC210 to have significant benefit in PTSD provided that adequate blood levels are achieved. This analysis provides a basis for optimal design of future trials to demonstrate efficacy.”
Bionomics said it will now seek FDA guidance on the next steps for BNC210 in PTSD including the design of a further trial and whether it is eligible for a Fast Track designation. It said it will continue to evaluate partnership opportunities in parallel and that the new data will also form part of the ongoing strategic review being conducted by Greenhill & Co.