Ann: Further Analysis of Phase 2 PTSD Trial Results Presentation, page-13

Investors have been led a merry dance with this one. Days of 12c behind us for the time being. I am guessing difficulties feeding elderly patients with the BNC210 dose in the Agitation trial woke them up to the fact of dosage issues with patients in the completed PTSD trial. Maybe the Agitation trial is being redone, and that is why the extra delays in reporting top line results. If the Agitation trial fails BNO is still RIP.

Web roundup:
https://au.finance.yahoo.com/news/why-automotive-holdings-bionomics-breville-020328523.html
The Bionomics Ltd (ASX: BNO) share price has rocketed 67% to 20 cents. This morning the biotechnology company announced a promising new development for its key BNC210 drug candidate. Further data analysis of its disappointing Phase 2 Post Traumatic Stress Disorder (PTSD) trial has shown the potential for significant patient benefit when the drug exposure is adequate.

https://smallcaps.com.au/further-analysis-phase-2-findings-bionomics-ptsd-drug/
The exposure-response analysis used patient blood levels of the drug, regardless of the administered dose, to relate drug exposure to the response measured in the trial patients.
It used a liquid formulation of BNC210 and patients were required to take the drug with food, however results indicated that the liquid did not give sufficient exposure in an outpatient setting.
A pharmacometric analysis conducted post-trial quantified the level of efficacy of BNC210 on the overall CAPS-5 score related to exposure (blood levels) of the drug.
Bionomics will now seek FDA guidance on the next steps for BNC210 as it relates to PTSD treatment, including the design of a further trial and determination of whether BNC210 is eligible for “fast track” designation.
The company is also investigating an improved solid dose formulation of the drug in healthy human volunteers which may overcome the need for it to be taken with food.
The solid dose formulation of BNC210 is anticipated to be used in future PTSD trials.

https://unauthorised investment adv...sd-drug-might-work-after-all-shares-fly-75pc/
A spokesman for the company said the original trial included people who didn’t take the drug properly — with food — and later analysis showed that among those who did take the drug correctly, it remained in the patients’ bloodstream and did have a positive effect on PTSD symptoms.
Bionomics chairman Dr Errol De Souza says it vindicates the company’s decision to seek to treat PTSD with BNC210, even though it stopped nearly all work on the drug, lost its CEO and underwent a recapitalisation and strategic review after the initial news.
“At the time of the top-line 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,” Dr De Souza told investors.
“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.”
Bionomics now says it is completely revitalising BNC210 with regards to PTSD, saying it will seek guidance from the US Food and Drug Administration (FDA) on the next steps including the design of a further trial and whether the drug is eligible for fast track designation.
The new data will also be taken into consideration for the strategic review, being conducted in conjunction with investment bank advisors Greenhill.
“Exposure-response modelling has shown the potential for BNC210 to have significant benefit in PTSD provided that adequate blood levels are achieved,” he said. “This analysis provides a basis for optimal design of future trials to demonstrate efficacy.”
The company is also testing BNC210 in elderly patients with agitation issues and has a range of other candidates in experimental trials.