Further Data Analysis of Bionomics’ Phase 2 Post Traumatic Stress Disorder Trial Shows the Potential for Significant Patient Benefit When Drug Exposure Is Adequate

  • Additional work undertaken on a drug exposure-response analysis
    shows a statistically significant response of BNC210 in treatment of
    PTSD symptoms, as measured by CAPS-5 at 12 weeks.
  • Bionomics will now seek FDA guidance on next steps for BNC210 for
    PTSD including the design of a further trial and whether BNC210 is
    eligible for Fast Track designation.
  • Variable absorption of the liquid formulation of BNC210 used in the
    PTSD trial and the requirement for the drug to be taken with food may
    be overcome through development of an improved solid dose formulation
    which has recently been evaluated in healthy human volunteers. The
    solid dose formulation of BNC210 is anticipated to be used in any
    future PTSD trials.
  • It is intended that the data from the ongoing BNC210 trial in
    Agitation will be analysed by dose and by measures of exposure given
    the PTSD trial learnings. Consequently, this trial is anticipated to
    read out in Q2, 2019.

ADELAIDE, Australia–(BUSINESS WIRE)–Bionomics Limited (ASX:BNO, OTCQX:BNOEF), a global, clinical stage
biopharmaceutical company, announces that an additional data analysis
conducted in Sweden by Pharmetheus AB showed a statistically significant
response when drug exposure versus response was measured in the Phase 2
PTSD Trial (referred to as the RESTORE trial). 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. The analysis demonstrated reduction in total PTSD
symptoms as measured by total CAPS-5, the endpoint mandated by the US
Food & Drug Administration (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.

A pharmacometric analysis has now been performed on the RESTORE trial.
This analysis was conducted by Pharmetheus AB, an international
pharmacometrics consulting company with extensive scientific and
regulatory expertise, under the supervision of Advisor 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.

Prof Karlsson states “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 will now seek 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. Bionomics will continue to evaluate
partnership opportunities in parallel. These new data will also form
part of the ongoing strategic review being conducted by Greenhill & Co.

Bionomics has now identified an improved solid dose formulation of
BNC210 with potential to overcome the “food effect” and the consequent
variable blood levels that were evident in the PTSD trial where the
patients were administered BNC210 in a liquid formulation. It is
anticipated that the solid dose formulation will be used in any future
PTSD trials.

In relation to the ongoing Phase 2 exploratory clinical trial of BNC210
in elderly patients with Agitation, Bionomics intends to conduct similar
exposure-response analyses. Full recruitment in this trial is
anticipated toward the end of Q1, with data expected to be available in
late Q2, 2019.

The Phase 2 RESTORE Trial

The RESTORE trial was a randomised, double-blinded, placebo-controlled
Phase 2 clinical trial that enrolled 193 adult patients diagnosed with
PTSD across 20 sites in United States and 6 sites in Australia. The
primary endpoint of this study was a decrease in PTSD symptoms between
placebo and BNC210 treatment groups as measured by the
Clinician-Administered PTSD Scale (CAPS-5) at 12 weeks. The CAPS-5 is a
standardised structured clinical interview and serves as the standard in
research for measuring the symptom severity of PTSD. Earlier versions of
the CAPS were used to support the approval of the two currently marketed
PTSD treatments. Secondary endpoints included measurement of effects on
components of the CAPS-5 and PTSD symptom clusters, measures of anxiety
and depression, well-being, sleep and safety.

About Bionomics Limited

Bionomics (ASX: BNO) is a global, clinical stage biopharmaceutical
company leveraging its proprietary platform technologies to discover and
develop a deep pipeline of best in class, novel drug candidates.
Bionomics’ lead drug candidate BNC210, currently in Phase 2 for the
treatment of agitation, is a novel, proprietary negative allosteric
modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Beyond
BNC210, Bionomics has a strategic partnership with Merck & Co., Inc
(known as MSD outside the United States and Canada) and a pipeline of
pre-clinical ion channel programs targeting pain, depression, cognition
and epilepsy.


Factors Affecting Future Performance

This announcement contains “forward-looking” statements within the
meaning of the United States’ Private Securities Litigation Reform Act
of 1995. Any statements contained in this announcement that relate to
prospective events or developments, including, without limitation,
statements made regarding Bionomics’ drug candidates (including BNC210),
its licensing agreements with Merck & Co. and any milestone or royalty
payments thereunder, drug discovery programs, ongoing and future
clinical trials, and timing of the receipt of clinical data for our drug
candidates are deemed to be forward-looking statements. Words such as
“believes,” “anticipates,” “plans,” “expects,” “projects,” “forecasts,”
“will” and similar expressions are intended to identify forward-looking

There are a number of important factors that could cause actual results
or events to differ materially from those indicated by these
forward-looking statements, including unexpected safety or efficacy
data, unexpected side effects observed in clinical trials, risks related
to our available funds or existing funding arrangements, our failure to
introduce new drug candidates or platform technologies or obtain
regulatory approvals in a timely manner or at all, regulatory changes,
inability to protect our intellectual property, risks related to our
international operations, our inability to integrate acquired businesses
and technologies into our existing business and to our competitive
advantage, as well as other factors. Results of studies performed on our
drug candidates and competitors’ drugs and drug candidates may vary from
those reported when tested in different settings.


Rudi Michelson
+613 9620 3333

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