Tryp Therapeutics has dosed the first subject in Phase II clinical trial for its lead candidate, TRP-8802 plus psychotherapy TRP-8802 to potentially treat binge eating disorder (BED).

TRP-8802 is a non-proprietary 25mg oral capsule of synthetic psilocybin.

Up to ten BED patients have been dosed in the trial of TRP-8802 plus psychotherapy. 

In partnership with the University of Florida in the US, the open-label, exploratory trial will assess the safety and initial efficacy of psilocybin-assisted therapy in BED patients.

The trial will aid the company in monitoring study data on an ongoing basis.

It will use psychotherapy protocols developed along with Fluence and its team of researchers and clinicians who have knowledge in psychedelic trials and psychotherapeutic training capabilities to aid healthcare professionals.

Tryp Therapeutics chief scientific officer and interim CEO Dr Jim Gilligan said: “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. 

“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.”

BED is defined by recurring incidences of eating huge quantities of food and feeling unable to stop.

The Phase IIa trials of TRP-8802 will aid the company to rapidly commence trials to produce preliminary data while they simultaneously develop an enhanced, proprietary formulation and delivery system, TRP-8803, for psilocybin-related molecules for target indications such as BED.