Tryptamine Therapeutics (ASX:TYP) has received approval from the Swinburne University Human Research Ethics Committee to initiate a world-first clinical trial of TRP-8803 for adult patients with Binge Eating Disorder (BED).
TRP-8803 is Tryptamine's proprietary psilocin-based, intravenously-infused formulation. The trial, to be conducted in collaboration with Swinburne University, will assess the safety, efficacy and dosing flexibility of TRP-8803 when administered in combination with psychotherapy.
The open-label trial will dose 12 participants suffering from BED in two patient cohorts. Each cohort will be administered two doses of TRP-8803, 14 days apart, in a monitored setting. Both patient cohorts will receive Tryptamine's target therapeutic dose level, with cohort one receiving the dose over 140 minutes and cohort two receiving the dose over 60 minutes.
Tryptamine said TRP-8803 will be administered to patients following preparatory psychotherapy and integration initiatives. It said the trial’s primary objective is to assess the safety and efficacy of two doses of TRP-8803 in BED patients and throughout follow-up during the 12 weeks following the second dose.
Secondary and exploratory objectives include evaluating the ability of TRP-8803 to induce a psychedelic state and the effects of the frequency of binge-eating episodes and other weight-related indicators over four and 12 weeks from the second dosing.
The company is pursuing BED as it is the most common eating disorder in the US and the second most common in Australia. The condition is associated with both obesity and neuropsychiatric comorbidities, with sufferers often experiencing anxiety, depression, PTSD, as well as impulsive and compulsive behaviours.
The trial follows positive interim data from the company’s study in collaboration with the University of Florida for the application of oral TRP-8802 (oral psilocybin) which demonstrated around 80 per cent improvement in patient Binge Eating scores.
Tryptamine CEO Jason Carroll said, “While Binge Eating Disorder is not widely publicised, it is incredibly widespread with many sufferers also experiencing a range of other neuropsychiatric conditions including anxiety, depression and PTSD amongst others. While the primary objective of this world first trial is to assess TRP-8803’s utility in Binge Eating Disorder, it will also provide valuable insight into how TRP-8803 may help with other neuropsychiatric disorders, in line with the Company’s goal of delivering treatments to large, unmet conditions.
"With patient recruitment initiatives now underway, we look forward to first enrolment and the commencement of baseline data generation from participants, prior to first patient dosing.
"We look forward to providing additional updates on our work with Swinburne over the coming weeks.”