At the Royal Adelaide Hospital in Australia, a new study is now underway that could potentially expand the catalogue of treatments available for individuals seeking psychoactive therapy.
On Thursday, Field Trip Health Ltd. (TSX: FTRP, FTRP.WT, Nasdaq: FTRP) announced that it had successfully administered the first dose of a new psychoactive synthetic molecule in a 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 HCI in Healthy Volunteers.
FT-104 is a prodrug of 4-OH-DiPT (similar to how psilocybin is a prodrug for its active compound, psilocin), a synthetic serotonin 2A agonist — essentially meaning it is an artificial compound that can activate and bind to a receptor in the brain, therefore mimicking a neurotransmitter.
The company also announced that prior to the end of this summer it would be changing its name to Reunion Neuroscience Inc.
Field Trip describes itself as a global leader in the development and delivery of psychedelic therapies. The company claims that its Field Trip Discovery division is pioneering the development of future psychoactive molecules and engaging in state-of-the-art research endeavours investigating plant-derived psychedelics.
The organization also proudly states that its Field Trip Health division has been constructing centres for psychedelic therapy throughout North America and Europe — with facilities already established in Vancouver, Toronto, Chicago, Houston, Amsterdam and several other cities. The Canadian company’s international presence is also quite evident with this new clinical trial taking place down under.
According to the company, pre-clinical data has indicated that FT-104 has similar characteristics to psilocybin with regard to its pharmacology and potency. However, Field Trip claims that the half-life (amount of time it takes for an active pharmaceutical ingredient to dissipate by over 50 per cent within the body) of its new molecule is significantly shorter than the magic mushroom compound at only 35 minutes. The anticipated trip duration for FT-104 will be approximately three hours.
Field Trip believes its new synthetic molecule could provide a relatively quick, safe and efficient means of treating an assortment of mental health ailments when provided in unison with psychotherapy.
“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,” said Dr. Nathan Bryson, Chief Scientific Officer at Field Trip Health.
The primary goals for the ongoing phase 1 study will be to assess the safety, pharmacodynamic effects, tolerability and pharmacokinetic outcomes of FT-104 through a series of doses administered to multiple subjects. In simple terms, pharmacodynamics represent the impact a drug has on the body and pharmacokinetics reveal the effects that the body has on a drug.
Subjective critiques provided by test subjects will include assessments on level of intensity and experience duration.
Field Trip plans to report its findings from the newly announced clinical study this fall in Q4.
Beginning in August or early September the company will be listed as “Reunion” on the Toronto Stock Exchange and NASDAQ Stock Market.