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Field Trip Health Ltd. Provides Update on FT-104, Its Next Generation Psychedelic Molecule in Development

Your Brief & Snap Interview

Field Trip’s novel psychedelic molecule, FT-104, is found to be similar in potency to psilocybin but with a shorter duration of psychoactivity. The half-life of the molecule is roughly one third of psilocybin’s.

This makes it a potentially preferable option for related therapies.

This is further to the results announced in late September, which demonstrated successful GLP synthesis and that the molecule is a serotonin 5HT2a receptor agonist.

We asked Executive Chairman Ronan Levy two questions:

Psilocybin Alpha: The 89% bioavailability cited is based on subcutaneous delivery. Does the team envisage this being the delivery method that is ultimately used? If not, how might different delivery methods affect this?

Ronan Levy: The structure of the active molecule of FT-104 gives us flexibility on the method of delivery, of which subcutaneous injection is an option, but oral administration is an option as well. As with most alternative forms of administration, bioavailability and onset may be changed depending on the format.

Psilocybin Alpha: When can we expect to see clinical studies for this molecule?

Ronan Levy: We expect to be in Phase 1 human trials before the end of next year.

Full release below…


Results confirm that Field Trip’s novel psychedelic molecule is similar in potency to psilocybin but with shorter duration of psychoactivity making it a potentially preferable option for psychedelic therapies

TORONTO, Oct. 29, 2020 /CNW/ — Field Trip Health Ltd. (CSE: FTRP) (OTC: FTRPF) (“Field Trip”), the leader in the development and delivery of psychedelic therapies, today provided an update on its in-vivo and in-vitro studies on FT-104, its lead drug candidate.

Further to its announcement on September 29, 2020, confirming both the successful GLP synthesis of FT-104 and that FT-104 is a serotonin 5HT2A receptor agonist (the serotonin receptor believed responsible for psychedelic experiences), Field Trip announced that FT-104 is a potent psychedelic molecule with rapid onset and a short duration.

Notably, Field Trip reported:

  • FT-104’s binding constant (Ki) for the 5HT2A receptor is 120 nM, which indicates a potency similar to psilocybin1;
  • A 2mg/kg subcutaneous dose of FT104 to rats resulted in peak concentrations (Cmax) of the active agonist of 150+/-51 ng/ml at 60 min (Tmax) and bioavailability of 89%.
  • The elimination of FT-104 from the bloodstream has a half-life (t1/2) of 40min, which compares to psilocybin with a half-life on the order of 120min2;
  • A head twitch response (“HTR”) was observed after administration of FT-104. The intensity of the HTR correlated well with plasma levels of the active which suggests that the EC50 (50% effective concentration) for the HTR is in the range of 100 ng/ml. It has been shown that the HTR in rodents is related to the intensity of psychedelic activity of a psychedelic substance, and thus, is an indicator of its potential for use as a catalyst to treat mood disorders.

In summary, these experiments demonstrate that: (i) FT-104 is a near equipotent 5HT2A receptor agonist to psilocybin that can be delivered with high bioavailability; and (ii)  FT-104 will likely produce a reliably short-duration of psychedelic experience in the range of two to four hours, which is approximately half the duration of psilocybin.

“As we formulated our drug development strategy, we focused on new molecules (NCEs) that: (i) offer shorter duration of psychedelic experiences to make them more practical and convenient for use in the clinic; (ii) had similar potency to psilocybin or MDMA; (iii) had low potential for addiction; and (iv) would be simple to synthesize while differentiated and structurally distinct from psilocybin or other existing 5HT2A receptor agonists,” commented Dr. Nathan Bryson, Field Trip’s Chief Science Officer. “After significant research and due diligence, we initiated synthesis of a battery of small molecules, from which FT-104 was selected as our lead molecule. I am excited to take FT-104 into the next phases of our drug development program.”

FT-104 is a novel, synthetic psychedelic molecule developed by Field Trip inspired by the chemical structures of known psychedelic substances. FT-104 was selected for its simplicity as well as its potential to distinguish itself with respect to its pharmacological features relative to naturally-derived substances, such as psilocybin, DMT and LSD.

“Drugs like psilocybin and MDMA are showing significant efficacy in treating conditions like depression and PTSD,” said Dieter Weinand, Field Trip Board Member and former Chairman and CEO of Bayer Pharmaceuticals AG. “However, the relatively slow onset, and long duration of those drugs, which can result in treatment times lasting from 6 to 10 hours or more, makes them less attractive to patients and clinicians because of the time and treatment infrastructure required. Not to mention, they are not, generally speaking, protectable by intellectual property.”

“If the results suggested by these preliminary studies for FT-104 are confirmed in clinical studies, FT-104 will address several notable limitations of psilocybin and MDMA.  Plus, it would be more convenient,” added Weinand, “which could make it a first choice for clinicians and a better treatment option than psilocybin.” 

Ronan Levy, Field Trip’s Executive Chairman noted, “Since inception, our philosophy at Field Trip has been that any psychedelics company needs to focus on both the development of psychedelic medicines and the delivery of psychedelic therapies.  We’ve always known that the Field Trip Health centers rolling out across North America would give us a competitive advantage in understanding and meeting the challenges of psychedelic medicine. Now, the latest results with FT104 suggest that Field Trip will also be the leader in the development of new psychedelic therapeutics.”

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With Field Trip Discovery leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics, Field Trip Health hubs for psychedelic therapies opening across North America, and Field Trip Digital building the digital and technological tools to support psychedelic experiences and consciousness expansion, we help people, from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com and https://www.fieldtriphealth.com.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967. 

Cautionary Note Regarding Forward-Looking Information.
This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business, which may include, but are not limited to, statements with respect to the listing of the common shares of Field Trip on the Canadian Securities Exchange, and the timing of such events. 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 risks regarding 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.

The CSE has neither approved nor disapproved the contents of this news release.

Media contacts:

Paige Tatulli
Autumn Communications
212-206-9780
paiget@autumncommunications.com / fieldtrip@autumncommunications.com

Investor contacts:

Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

1 Source: www.pdsp.unc.edu
2 Source: Chen 2011 JChromB, gives values of 117min (alpha) and 148 min (beta).

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SOURCE Field Trip Health Ltd.