Clinical-stage psychedelics biotech Tryp Therapeutics, Inc. (OTCQB:TRYPF) shared the interim results for the first five patients dosed in its Phase 2 STOP (Study of the Treatment of Overeating utilizing Psilocybin) trial.
The STOP trial, done in collaboration with the University of Florida, is evaluating proprietary oral psilocybin TRP-8802 in patients with Binge Eating Disorder (BED). The study constitutes the first use of psilocybin in conjunction with psychotherapy as a therapeutic intervention in patients with BED.
"The magnitude and consistency of the trends observed in this interim analysis are incredibly encouraging," said Tryp's CEO Dr. Jim Gilligan: "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."
Gilligan added that Tryp's strategy consists of performing small exploratory studies using TRP-8802 for unique indications including BED, fibromyalgia and irritable bowel syndrome in partnership with renowned academic institutions. "Once a positive clinical signal is identified in studies using TRP-8802, we intend to perform subsequent studies with TRP-8803."
The Results
The company reported that immediately after the post-dosing integration session and throughout the four-week period following, the first patient showed reduced overall anxiety, food-induced anxiety and the compulsion to overeat as well as improved self-image and confidence.
Analysis of four additional patients reinforced the initial clinical observations with current results noting a significant reduction in the frequency of binge eating behavior for each patient as well as a favorable safety profile as measured in the four-week period multiple efficacy assessments that make up the trial's primary endpoints.
More specifically, outcomes showed daily binge eating episodes reduced by an average of 80.4% from baseline during the four-week post-dosing period, with all patients exhibiting a daily reduction in binge eating episodes of at least 60% from baseline and the number of daily instances of patients feeling lost control over their eating were reduced by an average of 81.6% during that same period.
In addition, analysis of the Hospital Anxiety and Depression Scale (HADS) scores showed improving trends related to patients' baseline levels of anxiety and depression.
"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," said Dr. Jesse Dallery, lead psychologist for the STOP study.
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