Further Data Analysis of Bionomics’ Phase 2 Post Traumatic Stress Disorder Trial Shows the Potential for Significant Patien...
February 18 2019 - 6:00AM
Business Wire
- 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.
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.
www.bionomics.com.au
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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,"
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and similar expressions are intended to identify forward-looking
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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
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manner or at all, regulatory changes, inability to protect our
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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.
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CONTACT:AustraliaMonsoon CommunicationsRudi
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