Field Trip, a leader in the development and delivery of psychedelic therapies, has announced the lead indications for FT-104, its novel psychedelic compound in development, will be Treatment Resistant Depression (TRD) and Postpartum Depression (PPD).
Through Field Trip Discovery, its drug development division, Field Trip is developing next-generation psychedelic molecules. Its first molecule in development, FT-104, a prodrug, is a synthetic serotonin-2A (5HT2A) agonist whose active component has serotonin-2A potency similar to psilocybin. Importantly, however, the active component of FT-104 is expected to produce a reliably shorter duration of psychoactivity (2-3 hours) than psilocybin, and has high bioavailability after administration.
Preclinical activities, that will enable commencement of Phase I clinical trials in Q1 2022, are ongoing and are expected to continue through to the end of 2021. After completion of the Phase 1 and opening of a US-IND, Field Trip intends to initiate Phase IIA studies in TRD, following which Phase II studies in TRD and PPD are expected to be conducted substantially in parallel.
Postpartum depression affects about 10-15% of all mothers of newborns, with an estimated prevalence of 400,000 diagnosed patients in the U.S. per year. The only currently approved therapy for PPD requires a significant time commitment away from family and newborn (2.5-3 days) while serotonin reuptake inhibitors (SSRIs) used off-label take a long time for onset and only show limited efficacy. This represents a potential concern for the safety, well-being and long-term development of the child.
It is estimated that, globally, there are 322 million people who suffer from major depressive disorders, of which approximately 33%, or 100 million people, meet the diagnostic criteria for TRD. There are few alternatives for people suffering with TRD and those who are diagnosed with TRD have typically failed first and second line therapies, thus TRD represents a significant unmet need for effective treatments. Beyond the quality of life impacts, people with TRD have higher costs of care and tend to experience decreased work productivity.
Dr. Nathan Bryson, Field Trip’s Chief Scientific Officer, said, “Given our encouraging preclinical results to date, we believe that FT-104 has the potential to transform approaches to hard-to-treat depressive disorders. Our preclinical activities are expected to continue through 2021 with the goal of determining the pharmacokinetics, metabolism and routes of elimination in animal species, as well as safety pharmacology. Selecting our two main indications is a significant milestone for Field Trip, and will guide our clinical strategy as we design our Phase II trials and work toward drug commercialization.”
Joseph del Moral, Field Trip’s CEO, said, “The decision to pursue TRD and PPD in parallel is the result of a comprehensive strategic assessment of FT-104’s unique and desirable characteristics. TRD represents a tremendous market opportunity for which we believe FT-104 will rapidly become a preferred treatment option, especially relative to psilocybin. Notably, PPD is an acute condition with a lower regulatory burden and shorter overall timelines for approval making FT-104 a potential first-in-class for PPD. By pursuing TRD and PPD in parallel, we can achieve both speed and scale for FT-104.”