Psychedelics biopharma company Reunion Neuroscience Inc. REUN announced it is undertaking a Phase 1 clinical trial on RE104, which is a novel serotonergic substance that could treat postpartum depression.
32 healthy participants were divided into four ascending-dose cohorts, two of the eight subjects in each cohort receiving a placebo. RE104 not only checked for safety and tolerability with no severe adverse effects but also showed robust and extensive effects with a shorter duration of the psychedelic experience -approx. three to four hours.
The study identified an optimal single dose, by which most participants achieved a “complete mystical experience” defined as a 60% and higher score in all four domains of the Mystical Experience Questionnaire (MEQ30).
Following this measuring instrument, a complete mystical experience has been shown to correlate with psychedelic treatment responses in trials of patients with depression, anxiety and substance use disorder.
Reunion has continued testing dose escalation with a fifth cohort and could potentially include a sixth.
The company intends to share these positive results with the FDA as part of a pre-Investigational New Drug (IND) meeting toward Phase 2 program development in postpartum depression. Public sharing of the full Phase 1 dataset is planned for the first half of 2023.
“We are confident that this data provides robust justification for selecting a dose of RE104 that could yield clinical efficacy in the treatment of postpartum depression,” said president and CEO Greg Mayes. “Innovation in the development of mental health treatment is severely lacking and has failed to provide meaningful change in how we approach these all-too-common conditions, especially with respect to women’s mental health.”
Photo: Benzinga edit with photo by Marcos Mesa Sam Wordley and Zita on Shutterstock.