TIDMPRTC
RNS Number : 4082S
PureTech Health PLC
20 December 2016
20 December 2016
PureTech Health plc
PureTech Health Announces Results from Two Studies of Tal
Medical's LFMS Technology in Treatment-Resistant Major Depressive
Disorder
Tal dose optimisation study showed consistent dose-dependent
effect across multiple measurements but did not achieve statistical
significance
Weill Cornell fMRI study demonstrated effects on brain activity
in networks associated with depression
Tal Medical, a clinical stage neuroscience company focused on
the development of a non-invasive neuromodulation therapy and a
subsidiary of PureTech Health (LSE: PRTC), today announced results
from two studies evaluating Tal's proprietary Low Field Magnetic
Stimulation (LFMS) technology in treatment-resistant major
depressive disorder (TR-MDD). A Tal dose optimisation study did not
meet statistical significance on its Hamilton Depression Rating
Scale (HAMD6) primary endpoint, although it showed a
rapidly-acting, trending effect across multiple measurements in a
dose-dependent manner. Separately, a functional magnetic resonance
imaging (fMRI) study at Weill Cornell Medical College showed a
reduction in functional connectivity in brain networks associated
with depression after LFMS treatment.
"Given these latest results and the data from the RAPID trial
reported in June, we will assess the utilisation of Tal resources
and previously-earmarked PureTech cash and re-allocate as
appropriate," said Daphne Zohar, PureTech Co-founder and CEO. "We
will continue to analyse the full results from these studies in
order to determine the best potential clinical application for this
technology."
"Although we did not achieve statistical significance on the
primary endpoint of our dosing study, the observed magnitude of the
effect achieved in 2 to 4 days is on par with or higher than what
antidepressant drugs typically achieve in 4 to 10 weeks and with a
good safety profile," said Jan Skvarka, Tal Medical CEO. "We are
considering several options to potentially increase the effect size
and statistical power, including working with strategic partners
and our trusted academic collaborators through non-dilutive
sources."
"The data from both our dose ranging and Weill Cornell studies
are encouraging and further suggest that LFMS has rapidly-acting
effects on mood." said Steve Paul M.D., Tal Co-founder and Board
Member. "Importantly, the dose-dependent effects of LFMS on
self-rated as well as investigator-rated symptoms of depression
seen in our dose ranging study, coupled with a highly favourable
safety profile, support further work to optimise the LFMS field
properties for the potential treatment of clinical depression."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
About the Dose Optimisation Study
This study was designed to evaluate the effect of four
consecutive daily sessions of 20 or 60 minutes of LFMS compared to
sham treatment in subjects with TR-MDD (Week 1). In an exploratory
Week 2 treatment consisting of another four consecutive daily
sessions, Week-1 non-responders were randomised to receive either
120-minute LFMS or sham, while Week-1 responders were randomised to
continue their Week-1 regimen or receive sham. All subjects were
followed up for four weeks after the end of randomised treatment.
122 subjects were enrolled, and 120 completed Week 1 treatment and
were included in the primary analysis. The primary analysis of
baseline to endpoint change in HAMD6 showed a 1.0-point difference
between active 60-minute LFMS and sham at the end of Week 1, though
the difference was not statistically significant (p=0.31). On
MADRS, the study observed a 2.7-point difference, with a p value of
0.09 at the end of Week 1. Other secondary efficacy analyses showed
a consistently trending, dose-dependent effect favouring LFMS over
sham, with some analyses achieving a p value lower than 0.05 for
the 60-minute arm in Week 1. No safety issues were identified
during the study.
About the Weill Cornell fMRI Study
The fMRI study at Weill Cornell was designed to evaluate the
effect of LFMS on resting state functional connectivity within
multiple brain networks related to depressive symptoms in subjects
with TR-MDD. Symptoms were assessed using the 6-Item Hamilton
Depression Rating Scale (HAMD6), Visual Analog Scale (VAS), and
Positive and Negative Affect Schedule (PANAS) instruments. 66
subjects were enrolled, of whom 33 met the inclusion/exclusion
criteria and were included in the per protocol analysis. The
subjects underwent three 20-min LFMS treatments, as well as two
fMRI imaging sessions (before and after the treatment regimen). In
the per protocol sample, functional connectivity was reduced after
active, but not sham, treatment in networks underlying negative
rumination, attention and task performance. Several regions of
functional connectivity change were statistically significant and
specific to active-treatment responders. The per protocol sample
also showed greater pre- to post-treatment reduction in the active
LFMS vs sham group on HAMD-6 and VAS (p= 0.02 and 0.002, resp.),
though no meaningful difference was observed on PANAS. In the
intent-to-treat analysis, a greater pre- to post active vs sham
treatment reduction was observed on VAS (p=0.02), with no
meaningful difference on HAMD6 and PANAS. Marc Dubin, M.D., Ph.D.,
Assistant Professor of Clinical Psychiatry and of Neuroscience in
the Feil Family Brain and Mind Research Institute, and Director of
Non-Invasive Brain Stimulation in the Department of Psychiatry at
Weill Cornell Medicine was the study lead principal
investigator.
About Tal Medical and Low Field Magnetic Stimulation
Tal Medical is a clinical stage neuroscience company developing
a non-invasive neuromodulation therapy for depression and other
brain disorders. Tal's proprietary Low Field Magnetic Stimulation
(LFMS) technology uses a unique magnetic field waveform, with a
mechanism of action different from other brain stimulation
techniques such as electroconvulsive therapy (ECT) or transcranial
magnetic stimulation (TMS).
The previous proof-of-concept for LFMS was established at McLean
Hospital in two randomised, sham-controlled studies focused
primarily on bipolar depression. In those studies, a single
20-minute LFMS treatment demonstrated an immediate effect size
greater than antidepressant drug treatments typically achieve in
4-10 weeks. In June of this year, Tal and Massachusetts General
Hospital (MGH) reported topline data from the RAPID study of LFMS
in TR-MDD, in which treatment with LFMS did not achieve the primary
endpoint of HAMD6 after two 20 minute sessions in core depression
symptoms compared to sham treatment, though some non-statistically
significant mood improvements were detected with active LFMS on the
VAS instrument.
Tal Medical has an ongoing program in sleep along with several
additional mechanistic studies.
Tal's Board of Directors includes Steve Paul, M.D., former
president of the Lilly Research Laboratories of Eli Lilly and
Company; Ben Shapiro, M.D., former Executive Vice President of
Research for Merck and PureTech Health Non-Executive Director; Raju
Kucherlapati, founder and former Board member of Abgenix (acquired
by Amgen) and Millennium Pharmaceuticals (acquired by Takeda) and
PureTech Health Independent Non-Executive Director; and Daphne
Zohar, CEO and Co-founder of PureTech Health. Tal's Scientific
Advisory Board includes Atul Pande, M.D., Former Senior Vice
President, Head of Neuroscience and Senior Advisor, Pharmaceutical
R&D at GlaxoSmithKline and PureTech Health Senior Advisor; Mark
George, M.D., Layton McCurdy Endowed Chair, Distinguished Professor
of Psychiatry, Radiology and Neuroscience and Director of the Brain
Stimulation Laboratory at the Medical University of South Carolina;
Maurizio Fava, M.D., Executive Vice Chair for the MGH Department of
Psychiatry, Executive Director, MGH Clinical Trials Network and
Institute (CTNI) and Director, MGH Depression Clinical and Research
Program (DCRP); Robert Post, M.D., Former Chief of the Biological
Psychiatry Branch at the National Institute of Mental Health (NIMH)
and Professor of Psychiatry at George Washington University School
of Medicine and Head of the Bipolar Collaborative Network in
Bethesda, Maryland; and Hal Levine, D.O., EVP and Chief Medical
Officer of Beacon Health Options.
PureTech Health plc (PRTC.L) has moved Tal Medical from Growth
Stage to Project Phase. PureTech owns 54.2% of Tal on a diluted
basis as of 30 June 2016. The ownership calculation includes issued
and outstanding shares as well as options to purchase shares and
written commitments to issue shares or options, but excludes
unallocated shares authorised to be issued pursuant to equity
incentive plans and any convertible debt.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary biopharma company creating 21(st) century
medicines that modulate the adaptive human systems. Our therapies
target the immune, nervous, and gastro-intestinal systems by
addressing the underlying pathophysiology of disease from a systems
perspective rather than through a single receptor or pathway. We
are advancing more than 20 clinical studies across our pipeline,
with multiple human proof-of-concept studies and pivotal or
registration studies expected to read out in the next two years.
PureTech Health's rich and growing research and development
pipeline has been developed in collaboration with some of the
world's leading scientific experts, who along with PureTech's
experienced team and board analyses more than 650 scientific
discoveries per year to identify and advance the opportunities we
believe hold the most promise for patients. This team and process
place PureTech Health on the cutting edge of ground-breaking
science and technological innovation and leads the Company between
and beyond existing disciplines. For more information, visit
www.puretechhealth.com or connect with us on Twitter.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
For further information:
Media: Allison Mead
+1 617 651 3156
amead@puretechhealth.com
Investors: Graham Morrell
+1 617 986 1659
gm@puretechhealth.com
This information is provided by RNS
The company news service from the London Stock Exchange
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