Field Trip has now completed the dosing of the first patients in its Phase 1 clinical study: A double-blind, randomised, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single, ascending, subcutaneous doses of FT-104 HCl in healthy volunteers.
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 and an expected duration of psychoactivity 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 studies conducted at leading academic centres, Field Trip 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.
Field Trip’s Chief Scientific Officer, Dr Nathan Bryson, 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.”
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, and Field Trip anticipates reporting results from the study in Q4-2022.
To add to this development, the company has confirmed that shareholders of Field Trip approved the spin out transaction of Field Trip Health & Wellness Ltd. (FTHW), its clinic and technology division, by way of plan of arrangement.
Court approval for the arrangement was granted in June and closing remains subject to regulatory approvals, including the conditional listing approval of FTHW by the TSX Venture Exchange which 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.
Field Trip’s Co-founder and Chief Executive Officer, Joseph del Moral, 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.”
[activecampaign form=52]
