Tryp has announced interim data for the first five patients dosed in its Phase 2 trial, stating the data supports the potential effectiveness of psilocybin-assisted psychotherapy for the treatment of Binge Eating Disorder (BED).
The STOP (Study of the Treatment of Overeating utilizing Psilocybin) trial is being carried out in collaboration with the University of Florida. The trial represents the first use of psilocybin in conjunction with psychotherapy as a therapeutic intervention in patients with BED.
According to the company, the oral psilocybin formulation – TRP-8802 – demonstrated significant and prolonged improvement in primary endpoints for all five patients.
Previously, Tryp reported that immediately following the post-dosing integration session with the trial’s psychotherapists and throughout the four-week period post-dosing, the first patient in the STOP trial exhibited reduced overall anxiety, reduced anxiety around food, reduced compulsion to overeat and improved self-image and confidence.
Analysis of the additional four patients has reinforced the initial clinical observations. The current results demonstrated a significant reduction in the frequency of binge eating behaviour for each patient as measured in multiple assessments of efficacy which were discussed with the FDA as acceptable endpoints in advance of this study.
Lead psychologist for the STOP Study at the University of Florida, Dr Jesse Dallery, commented: “These results from a single dose of psilocybin combined with therapy are clinically meaningful and highly promising. The magnitude of changes for most participants in binge eating, anxiety, and depression are dramatic – the kind of changes we might see after much longer periods of evidence-based therapy.
“The “signal” here is highly positive for binge eating and other indicators of quality of life.”
STOP study interim results
Interim data has shown that across all patients, daily binge eating episodes were reduced by an average of 80.4% from baseline during the four-week post-dosing measurement period, with all patients reporting a daily reduction in binge eating episodes of at least 60% from baseline.
A total of 4 of 5 patients reported at least a 75% reduction in daily binge eating episodes from baseline during the four-week post-dosing measurement period, and the number of daily instances of patients feeling that they had lost control over their eating were reduced by an average of 81.6% during the four-week post-dosing measurement period, with 4 of 5 patients reporting a reduction of greater than 70%
Additionally, analysis of the Hospital Anxiety and Depression Scale (HADS) anxiety and depression scores demonstrated improving trends related to patients’ levels of anxiety and depression.
The observed behavioural improvements are consistent with those described in other clinical studies examining the clinical benefit of psilocybin as a therapeutic intervention in compulsion-related disorders.
There were no drug-related adverse events reported by these patients during the four-week period following dosing of TRP-8802.
Tryp CEO, Jim Gilligan, Ph.D., stated: “The magnitude and consistency of the trends observed in this interim analysis are incredibly encouraging.
“Furthermore, these preliminary results provide us with the confidence that BED is a viable target for future studies with psychedelic-assisted psychotherapy utilizing TRP-8803, our proprietary IV formulation of psilocin that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.
“Our strategy is to perform small exploratory studies using TRP-8802 for unique indications including BED, fibromyalgia and irritable bowel syndrome, all in partnership with leading academic institutions. Once a positive clinical signal is identified in studies using TRP-8802, we intend to perform subsequent studies with TRP-8803.”
