Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) ("Field
Trip"), a global leader in the development and delivery of
psychedelic therapies, announced today the lead indications for
FT-104, its novel psychedelic compound in development, will be
Treatment Resistant Depression (TRD) and Postpartum Depression
(PPD). Field Trip today also announced that Anita H. Clayton, MD,
Chair of Psychiatry and Neurobehavioral Sciences at the School of
Medicine at the University of Virginia, has joined its Scientific
Advisory board.
Through Field Trip Discovery, its drug
development division, Field Trip is developing next-generation
psychedelic molecules. Its first molecule in development, FT-104, a
prodrug, is a synthetic serotonin-2A (5HT2A) agonist whose active
component has serotonin-2A potency similar to psilocybin.
Importantly, however, the active component of FT-104 is expected to
produce a reliably shorter duration of psychoactivity (2-3 hours)
than psilocybin, and has high bioavailability after
administration.
Preclinical activities that will enable
commencement of Phase I clinical trials in calendar Q1 2022 are
ongoing and are expected to continue through to the end of calendar
2021. After completion of the Phase 1 and opening of a US-IND,
Field Trip intends to initiate Phase IIA studies in TRD, following
which Phase II studies in TRD and PPD are expected to be conducted
substantially in parallel.
Treatment Resistant
Depression
It is estimated that, globally, there are 322
million people who suffer from major depressive disorders1, of
which approximately 33%, or 100 million people, meet the diagnostic
criteria for TRD. There are few alternatives for people suffering
with TRD and those who are diagnosed with TRD have typically failed
first and second line therapies, thus TRD represents a significant
unmet need for effective treatments. Beyond the quality of life
impacts, people with TRD have higher costs of care and tend to
experience decreased work productivity.
Postpartum Depression
Postpartum depression affects about 10-15% of
all mothers of newborns, with an estimated prevalence of 400,000
diagnosed patients in the U.S. per year.2 The only currently
approved therapy for PPD requires a significant time commitment
away from family and newborn (2.5-3 days) while serotonin reuptake
inhibitors (SSRIs) used off-label take a long time for onset and
only show limited efficacy. This represents a potential concern for
the safety, well-being and long-term development of the
child.3
Dr. Nathan Bryson, Field Trip’s Chief Scientific
Officer, said, “Given our encouraging preclinical results to date,
we believe that FT-104 has the potential to transform approaches to
hard-to-treat depressive disorders. Our preclinical activities are
expected to continue through 2021 with the goal of determining the
pharmacokinetics, metabolism and routes of elimination in animal
species, as well as safety pharmacology. Selecting our two main
indications is a significant milestone for Field Trip, and will
guide our clinical strategy as we design our Phase II trials and
work toward drug commercialization.”
Joseph del Moral, Field Trip’s CEO, said, “The
decision to pursue TRD and PPD in parallel is the result of a
comprehensive strategic assessment of FT-104’s unique and desirable
characteristics. TRD represents a tremendous market opportunity for
which we believe FT-104 will rapidly become a preferred treatment
option, especially relative to psilocybin. Notably, PPD is an acute
condition with a lower regulatory burden and shorter overall
timelines for approval making FT-104 a potential first-in-class for
PPD. By pursuing TRD and PPD in parallel, we can achieve both speed
and scale for FT-104.”
“We are also delighted that Dr. Clayton has
joined our Advisory board. She is a widely known and highly
respected physician for the treatment of depression and PPD and our
future work will benefit from her extensive knowledge,” concluded
Mr. del Moral.
Appointment of Anita H. Clayton,
MD
Anita H. Clayton, MD is the David C. Wilson
Professor and Chair of Psychiatry & Neurobehavioral Sciences
and Professor of Clinical Obstetrics & Gynecology at the
University of Virginia. She has published over 200 peer-reviewed
papers, and was named to the 2019-2020 Best Doctors in America
list. She has focused her clinical practice and research on major
depressive disorder, mood disorders associated with
reproductive-life events in women including PPD, sexual
dysfunction, and sexual disorders.
“A significant population of patients with
depressive disorders do not find adequate symptom management from
the current options. Major depressive disorder (MDD),
treatment-resistant depression (TRD) and postpartum depression
(PPD) share similar etiologies and negatively impact functioning.
Women are twice as likely as men to be diagnosed with depression,
and a significant unmet need exists for TRD and PPD. Fast-acting
medicinal agents that provide immediate and long-lasting relief are
critically lacking. I am looking forward to examining whether the
serotonin agonist compound, FT-104, may have such effects,” added
Dr. Clayton.
About Field Trip Health Ltd.
Field Trip is a global leader in the development
and delivery of psychedelic therapies. With our Field Trip
Discovery division leading the development of the next generation
of psychedelic molecules and conducting advanced research on
plant-based psychedelics and our Field Trip Health division
building centers for psychedelic therapies opening across North
America and Europe along with the digital and technological tools
that will enable massive scale, we help people in need with a
simple, evidence-based way to heal and heighten engagement with the
world.
Learn more at https://www.meetfieldtrip.com,
https://www.fieldtriphealth.com and
https://www.fieldtriphealth.nl.
Follow us on Twitter and Instagram:
@fieldtriphealth
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Cautionary Note Regarding Forward-Looking
Information
This release includes forward-looking
information (within the meaning of Canadian securities laws and
within the meaning of the United States Private Securities
Litigation Reform Act of 1995) regarding Field Trip and its
business. Often but not always, forward-looking information can be
identified by the use of words such as "expect", "intends",
"anticipated", "believes" or variations (including negative
variations) of such words and phrases, or state that certain
actions, events or results "may", "could", "would" or "will" be
taken, occur or be achieved. Such statements are based on the
current expectations and views of future events of the management
of Field Trip, and are based on assumptions and subject to risks
and uncertainties. Although the management of Field Trip believes
that the assumptions underlying these statements are reasonable,
they may prove to be incorrect. The forward-looking events and
circumstances discussed in this release may not occur and could
differ materially as a result of known and unknown risk factors and
uncertainties affecting the companies, including interest in Field
Trip’s training program, interest in the KAP Co-Op Program, uptake
of the KAP Co-Op Program by therapists and patients, the timing and
results of its research and development programs, whether related
to TRD, PPD or otherwise, approval of phase 1 human trials, if any,
the risk that future clinical studies may not proceed as expected
or may produce unfavorable results, the opening of additional
clinics, the COVID-19 epidemic, the medical clinic industry, market
conditions, economic factors, management's ability to manage and to
operate the business and the equity markets generally. Although
Field Trip has attempted to identify important factors that could
cause actual actions, events or results to differ materially from
those described in forward-looking statements, there may be other
factors that cause actions, events or results to differ from those
anticipated, estimated or intended. Accordingly, readers should not
place undue reliance on any forward-looking statements or
information. No forward-looking statement can be guaranteed. Except
as required by applicable securities laws, forward-looking
statements speak only as of the date on which they are made and
Field Trip does not undertake any obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events, or otherwise.
This press release does not constitute an offer
to sell or the solicitation of an offer to buy securities.
Neither the Toronto Stock Exchange, nor its
Regulation Services Provider, have approved the contents of this
release or accept responsibility for the adequacy or accuracy of
this release.
Media contacts:McKenna MillerKCSA Strategic
Communications347-487-6197press@fieldtriphealth.com
Rachel MoskowitzAutumn
Communications202-276-7881press@fieldtriphealth.com
Investor contacts:Kathleen HeaneyKCSA Strategic
Communicationsfieldtripir@kcsa.com
SOURCE Field Trip Health Ltd.
1
https://jamanetwork.com/journals/jama/article-abstract/26186352
Gavin NI, Gaynes BN, et al. Obstetrics & Gynecology 2005, 106,
1071.3 Murray L, Cooper PJ Int. J Psychiatry 1996, 8, 55.
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