A Phase II trial is being conducted to investigate the potential of psilocybin-assisted psychotherapy as a treatment for binge eating disorder (BED).
According to Eating Disorder Hope, 2.8 percent of Americans over 18 will develop binge eating disorder in their life. The disorder is characterised by recurring episodes of eating large quantities of food and feeling unable to stop.
Whilst 43 per cent of individuals will obtain treatment for their disorder, these current therapies such as medicines, cognitive behaviour therapy (CBT) and medicines show limited effectiveness. This means there is a vital need for new treatments, as 5.2per cent of individuals suffering from eating disorders, including BED, die from health complications.
Tryp Therapeutics is now conducting its Phase II trial – which was approved by the FDA in 2021 – to determine the efficacy of its psilocybin candidate, TRP-8802, in combination with psychotherapy for the potential treatment of the disorder.
Chief scientific officer and interim CEO of Tryp Therapeutics, Dr Jim Gilligan, commented: “The world’s first FDA regulated clinical trial for psilocybin-assisted therapy targeting BED is underway, further advancing our clinical milestones.
“This is a key study for our psilocybin-assisted therapy portfolio as we assess the effectiveness of TRP-8802 (oral psilocybin) to treat patients with BED. There has been strong interest in trial recruitment to date.
“We believe that psilocybin-assisted therapy has the potential to offer a new therapeutic treatment for BED, a disorder that devastates the lives of over 250,000 people each year.”
The study will investigate the safety and preliminary efficacy of psilocybin-assisted therapy among patients with BED in collaboration with the University of Florida.
The trial will be leveraging psychotherapy protocols developed in conjunction with Fluence – an educational platform providing professional training in psychedelic therapy and psychedelic integration.
The first of up to 10 patients has now been dosed in this open-label, exploratory Phase II study.
Co-founder of Fluence, Ingmar Gorman, Ph.D., added: “We are thrilled to support Tryp’s BED program and be part of this historical event. Fluence is excited to assist Tryp in bringing innovative, psychedelic-based treatments to people struggling with overeating that will have a positive and lasting patient impact.”
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