Field Trip Health Ltd. (NASDAQ: FTRP, TSX: FTRP) ("Field Trip"), a
global leader in the development and delivery of psychedelic
therapies, today announced that the U.S. Patent and Trademark
Office (USPTO) has issued a Notice of Allowance for Field Trip’s
patent application No. 17/364,047 for claims related to FT-104
(informally known as “Isoprocin Glutarate”), Field Trip’s first
novel psychedelic molecule in development. Claims in the allowed
patent application titled, “Tryptamine Prodrugs”, cover composition
of matter, use and manufacturing of a family of hemi-ester
compounds of hydroxytryptamines, including FT-104.
Notices of Allowance are issued by the USPTO
after it has thoroughly examined a patent application to ensure it
complies with all requirements under United States patent law. This
includes a rigorous evaluation to confirm that the claimed subject
material is both novel and non-obvious with respect to prior art.
The formal granting of the patent will occur in a subsequent
administrative step.
The international (PCT) patent application
relating to FT-104, which was filed in June 2020, has also
published (WO 2022/000091) together with the International Search
Report (ISR), a first step before expansion into National Phase
filings to protect FT-104 in future major markets where Field Trip
intends to pursue commercialization should FT-104 achieve
regulatory approval. The international (PCT) patent application
provides Field Trip with deferred patent filing rights in 150+
countries.
Dr. Nathan Bryson, Field Trip’s Chief Science
Officer, commented: “Since inception, the strategy at Field Trip
for our first development project was to create a novel drug
substance that could produce a consistent trip time, in the range
of three hours. We achieved this by combining a novel prodrug
strategy to make demonstrable improvements on a known class of
psychedelic substances. To further derisk the project, we filed a
Track One U.S. patent application on June 30, 2021 in order to
accelerate the decision by examiners and achieve allowance, and
granting, as early as possible in the development process. We are
elated that the USPTO has formally allowed our patent application
within seven months of filing and are now poised to continue
development of FT-104 knowing that we have a robust intellectual
property position to build on.”
FT-104: A More Soluble, Stable Form of
4-HO-DiPT
The allowed patent application describes a
family of hemi-ester compounds of hydroxytryptamines, including
FT-104, a more soluble, more stable prodrug form of
4-hydroxy-N,N-diisopropyltryptamine (4-HO-DiPT or “Isoprocin”). The
preferred prodrug, FT-104, comprises the endogenous, natural
compound glutaric acid as a hemi-ester. As such, FT-104 has been
given a common name, Isoprocin Glutarate, for simplicity.
The psychedelic compound, 4-HO-DiPT, was
previously synthesized by Alexander (Sasha) Shulgin, a chemist and
psychopharmacologist, who not only self-administered many of the
substances he made but also reported their psychoactive effects in
the collective works called “Tryptamines I Have Known and Loved,”
or TIHKAL for short. In his works, Shulgin stated: “I truly doubt
that there is another psychedelic drug, anywhere, that can match
[4-HO-DiPT] for speed, intensity, brevity, and sensitive to dose,
at least one that is active orally,” adding that “To be on a trip,
then to be back pretty much in two hours and really baseline in
another hour? Most unusual. If there will ever be an acceptance of
drugs such as these, in a psychotherapeutic context, a short
duration is of extreme value to both the patient and the
therapist.”
FT-104 demonstrates improved stability and more
importantly improved solubility relative to 4-HO-DiPT. As a
prodrug, FT-104 converts rapidly and completely to 4-HO-DiPT after
administration. Combined, these properties result in improved drug
absorption, more reproducible pharmacokinetic profiles and improved
bioavailability relative to 4-HO-DiPT, making it a superior
development candidate.
Joseph del Moral, Field Trip’s CEO added: “We
designed FT-104 to provide a more convenient, practical and
consistent experience, while retaining the characteristics of a
classical serotonin psychedelic. These aspects are important
therapeutic and commercial differentiators which may truly separate
FT-104 from psilocybin for clinical operators and for patients
seeking psychedelic psychotherapy.”
Field Trip is currently closing out final
reports relating to preclinical assessments of safety and
toxicology in view of initiating a Phase 1 pharmacokinetic trial in
the first half of 2022.
Field Trip expects the patent for “Tryptamine
Prodrugs” to be issued in February 2022 and it will expire in
2040.
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 the uncertainties
inherent in research and development as well as risks associated
with preclinical and clinical data, including the possibility of
unfavorable new preclinical, clinical or safety data, further
analyses of existing preclinical data, the ability to produce
comparable results as hypothesized, if, when and whether any drug
applications maybe submitted and/or approved, decisions by
regulatory authorities, and/or other matters that could affect the
availability or commercial potential of FT-104, including
development of products or therapies by other companies,
availability and price of raw materials, availability of
manufacturing capacity on a timely basis and access to logistics or
supply channels commensurate with demand, the COVID-19 epidemic,
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:Autumn
Communications202-276-7881press@fieldtriphealth.com
Investor contacts:Kathleen Heaney / Tim
ReganKCSA Strategic CommunicationsfieldtripIR@kcsa.com
SOURCE Field Trip Health Ltd.
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