Field Trip Health Ltd. (TSX: FTRP, FTRP.WT, Nasdaq: FTRP) ("Field
Trip" or the “Company”), a global leader in the development and
delivery of psychedelic therapies, announced today the first
successful dosings in the Phase 1 Clinical Study entitled “A
Double-Blind, Randomized, Placebo-Controlled Study to Investigate
the Safety, Tolerability, and Pharmacokinetics of Single,
Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers.”
The study is being conducted at PARC Clinical Research at the Royal
Adelaide Hospital in Australia.
Field Trip's first molecule in development,
FT-104, is a prodrug of 4-OH-DiPT, a synthetic serotonin-2A (5HT2A)
agonist. Pre-clinical data suggests FT-104 has a potency and
pharmacology similar to psilocybin, but with a significantly
shorter half-life of approximately three hours. Based on the FT-104
pre-clinical profile projecting a reduced treatment burden, and
promising results from the early psilocybin therapy studies1
conducted at leading academic centers, the Company believes that
FT-104 could provide a rapid, safe and effective therapy for
depression and other mental health conditions when delivered in
conjunction with psychotherapy.
The key objectives of the Phase 1 study include
characterization of the safety, tolerability, pharmacokinetics and
pharmacodynamic effects of FT-104 over a range of doses. Subjective
measurements will include intensity, duration and feelings produced
by the acute psychoactivity after administration of FT-104 or
placebo. The Company anticipates reporting results from the study
in Q4-2022.
Dr. Nathan Bryson, Field Trip’s Chief Scientific
Officer, commented, “The first administration of a novel,
proprietary molecule is a landmark step for our Company and a key
milestone in our progress to develop FT-104 as a therapeutic for
depression. Already, we are planning to share our work and our
vision on the development of FT-104 in treatment-resistant
depression and postpartum depression with the FDA in order to
obtain their guidance as we look toward Phase 2 studies in
2023.”
Update on Spin-Out Transaction
In late June, shareholders of Field Trip
approved the spin out transaction of Field Trip Health &
Wellness Ltd. (“FTHW”), the Company’s clinic and technology
division, by way of plan of arrangement. Court approval for the
arrangement was granted in June. Closing remains subject to
regulatory approvals, including the conditional listing approval of
FTHW by the TSX Venture Exchange. It is expected that the closing
will occur on or around August 2022. At that time, the Company will
be renamed Reunion Neuroscience Inc. and remain listed on the
NASDAQ Stock Market and Toronto Stock Exchange (“Reunion”). Reunion
common shares will be consolidated on a 5:1 basis as part of the
closing of the spin out transaction.
Joseph del Moral, Field Trip’s Co-founder and
Chief Executive Officer, commented, “This is an incredibly exciting
time for our drug development business. Once the spin-out of FTHW
is completed, we will have a new name, a focused strategy, a
granted patent for FT-104, and an agreement between Reunion and
Field Trip Health & Wellness, giving us access to future
clinical trial sites.”
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 InformationThis 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, but not limited
to, statements the realization or results of proposed clinical
trials, the efficacy, if any, of FT-104 for TRD, PPD or any other
indication, approval of future clinical trials, and the ability of
Discovery to meet its estimated timelines, milestones and budget.
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.
Additional information relating to Field Trip, including its annual
information form, can be located on the SEDAR website at
www.sedar.com and on the EDGAR section of the SEC's website at
www.sec.gov.
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.
CONTACTS
Media Contacts:McKenna Miller / Nick OpichKCSA
Strategic Communicationsfieldtrip@kcsa.com
Investor Contacts:Kathleen Heaney / Sophia
BashfordKCSA Strategic CommunicationsfieldtripIR@kcsa.com
SOURCE: Field Trip Health
______________________________
1Ross et al, 2016; Griffiths et al, 2016; Carhart-Harris et al,
2016.
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