Developer and provider of psychedelic therapies Field Trip Health Ltd. has announced the first successful dosing of a Phase 1 clinical trial on it's proprietary psychedelic molecule.
The Phase 1 trial is a double-blind, randomized, placebo-controlled study investigating the safety, tolerability, and pharmacokinetics of single, subcutaneous dose of the compound, called FT-104 HCl, in healthy volunteers.
The trial, conducted at PARC Clinical Research at the Royal Adelaide Hospital in Australia, involves Field Trip's first proprietary molecule, FT-104, which is a prodrug of 4-OH-DiPT, a synthetic serotonin-2A (5HT2A) agonist, similar to LSD, psilocybin and DMT.
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.
The FT-104 pre-clinical profile projects a reduced treatment burden. Based on that and promising results from the early psilocybin therapy studies conducted at leading academic centers, Field Trip believes that their novel molecule could provide a rapid, safe and effective therapy for depression and other mental health conditions when delivered jointly with psychotherapy.
Indeed, the key goal of this phase 1 study is the 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 the drug or a placebo.
The company expects to report results from the study in Q4-2022. Field Trip’s chief scientific officer, Dr. Nathan Bryson, commented that this first administration of a proprietary molecule is a landmark step for the company, “and a key milestone in our progress to develop FT-104 as a therapeutic for depression.”
Bryson further added: “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.”
Spin-Out Transaction Update
A spin out transaction of Field Trip Health & Wellness Ltd. (FTHW), the company’s clinic and tech division, got court approval in June. Closing remains subject to regulatory approvals, yet it is expected to take place in August 2022, when the company will be renamed Reunion Neuroscience Inc.
Regarding the transaction and what it could mean for the company, Field Trip’s co-founder and CEO Joseph del Moral said: “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.”
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