TIDMPRTC
RNS Number : 9431Z
PureTech Health PLC
01 June 2016
PureTech Health plc
PureTech Announces Topline Data from Study of Tal Medical's LFMS
Technology in Treatment Resistant Depression
Boston, Massachusetts, June 1, 2016 - PureTech Health plc
("PureTech", LSE: PRTC), a cross-disciplinary healthcare company
tackling fundamental medical needs in disruptive ways, today
announced topline results from Tal Medical's first study focused on
major depressive disorder (MDD). The Rapidly Acting Treatments for
Treatment Resistant Depression (RAPID) program evaluated Tal
Medical's proprietary Low Field Magnetic Stimulation (LFMS)
technology in MDD resistant to one or more antidepressant
medications. Topline results of the study, which used the
sequential parallel comparison design (SPCD) and its two-stage
design, indicated that treatment with LFMS did not achieve the
primary endpoint of a 48-hour change in core depression symptoms
compared to sham treatment, as measured by the 6-item Hamilton
Depression Rating Scale or HAMD6. Some non-statistically
significant mood improvements were detected with active LFMS
compared to sham 120 minutes after the last administration in each
stage. No significant safety concerns were reported during the
study.
In two previous randomised, controlled studies focused primarily
on bipolar depression, a single, 20-minute LFMS treatment
demonstrated a statistically significant immediate effect size
greater than existing antidepressant drug treatments typically
achieve in 4-10 weeks. RAPID is the first study to evaluate Tal
Medical's technology in a clinical trial focused on MDD and also
the first to look at the 48-hour time point following the first
dose. Tal Medical expects several studies, including a dose
optimisation study in MDD and studies in additional indications, to
read out by the end of the year.
"Depression affects hundreds of millions of adults globally and
is the leading cause of suicide and disability worldwide. There is
an incredible unmet need for a safe, rapid-acting treatment since
it takes several weeks for medications to take effect," said the
study's principal investigator, Maurizio Fava, MD, Executive Vice
Chair, Department of Psychiatry and Executive Director, Clinical
Trials Network and Institute (CTNI), Massachusetts General
Hospital. "Many successful, FDA-approved antidepressant drugs have
had multiple negative clinical trials. Given the previous positive
clinical and preclinical data, I look forward to tracking the
progress of LFMS to determine its full potential in MDD, bipolar
depression and other indications."
Daphne Zohar, Co-founder and Chief Executive Officer at
PureTech, said: "Over the next six months we will have a large
amount of data to review as Tal completes multiple studies
evaluating dosing, length of effect, mechanism of action and
efficacy in other indications. These studies, in addition to Tal's
two previous positive studies focused primarily on bipolar
depression, will guide our understanding of the full potential for
Tal's technology."
About Depression
Depression affects more than 350 million adults globally, and
the most common forms are major depressive disorder and bipolar
disorder.
Major depressive disorder is primarily treated with
antidepressant drugs, yet there remains a vast, unmet need for a
safe, rapid-acting treatment. Antidepressants take 4-10 weeks to
work, leaving many patients at risk of prolonged suffering,
functional impairment or suicide. The current standard of care for
acute, unstable or severely depressed patients is hospitalisation.
Electro-convulsive therapy (ECT) is often the last resort, despite
safety risks, including memory loss.
Bipolar disorder, also known as manic-depressive illness, is a
brain disorder that causes unusual shifts in mood, energy, activity
levels, and the ability to carry out day-to-day tasks. Bipolar
disorder is the sixth leading cause of disability in the world.
About the RAPID LFMS Trial
The Rapidly Acting Treatments for Treatment Resistant Depression
(RAPID) trial was a double-blind, randomised, sham-controlled,
multi-site study of Tal Medical's first-in-class Low Field Magnetic
Stimulation (LFMS) technology in 85 treatment resistant major
depressive disorder (MDD) patients. Led by Massachusetts General
Hospital (MGH), RAPID tested 20 minute LFMS treatment sessions over
two and four consecutive days vs. sham and measured the effect
durability for one month. The primary endpoint was the reduction in
depressive symptoms at 48 hours (24 hours after second treatment)
on the 6-item Hamilton Depression Rating Scale (HAM-D-6) total
score. Secondary outcomes included other depression measures (e.g.,
PANAS, VAS, MADRS, CGI) as well as effect durability at a 4-week
follow-up.
This study has been funded in whole or in part with Federal
funds from the National Institute of Mental Health, National
Institutes of Health, Department of Health and Human Services,
under Contract No. HHSN2712011000061.
About Low Field Magnetic Stimulation
Tal Medical is developing a proprietary Low Field Magnetic
Stimulation (LFMS) technology that uses a unique magnetic field
waveform, with a mechanism of action different from existing
treatments, including other brain stimulation techniques such as
electroconvulsive therapy (ECT) or transcranial magnetic
stimulation (TMS).
The proof of concept for LFMS was established at McLean
Hospital, a Harvard University teaching hospital, in two
randomised, sham-controlled studies focused primarily on bipolar
depression (N=117). A single 20-minute LFMS treatment in these
studies demonstrated, with no major side effects, an immediate
effect size greater than antidepressant drug treatment typically
achieve in 4-10 weeks.
About Tal Medical
Tal Medical is a clinical-stage technology company developing a
rapid-acting, non-invasive neuromodulation therapy for depression.
The company aims to redefine the clinical practice of psychiatry by
introducing the first safe, acute depression treatment as a
standard of care. Tal Medical was founded in conjunction with
leading scientists in the fields of depression and
neuromodulation.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary healthcare company developing innovative
products that could improve the lives of patients. PureTech is
focused on areas of growing scientific and technical insights that
it believes are at an important inflection point, including the
central nervous, gastro-intestinal and immune systems, and the
interactions and signaling between them. PureTech has approximately
20 clinical studies across its pipeline targeting multi-billion
dollar market opportunities, including six human proof-of-concept
studies and multiple pivotal or registration study readouts
expected in the next two years. While inevitably some technologies
will not advance to commercialisation, PureTech's approach
preserves its options as most of the cash resides on a PureTech
parent company level, allowing PureTech to build value and divert
cash to its most successful programs as milestones are achieved.
PureTech has over 220 patents and patent applications. PureTech's
leading team and board, along with an advisory network of more than
60 expert founder-scientists and advisors across multiple
disciplines, gives PureTech access to potentially ground-breaking
science and technological innovation. With healthcare undergoing
major transformation, PureTech believes it is well positioned to
develop and launch medicines for the 21st century. For more
information, visit www.puretechhealth.com and 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, please contact:
PureTech
Julie DiCarlo, Senior Vice President,
Communications and Investor Relations +1 617 456 0032
FTI Consulting (Communications
adviser to PureTech) +44 (0)20 3727
Ben Atwell / Matthew Cole 1000
This information is provided by RNS
The company news service from the London Stock Exchange
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