Tryptamine Therapeutics Ltd has signed an agreement with Swinburne University for the world's first trial using TRP-8803 for the treatment of binge eating disorder. CEO Jason Carroll sat down with Proactive to discuss the results.
Reducing binge eating episodes
Proactive: So let's start with a quick rundown of the trial. What are you aiming to achieve?
Jason Carroll: I'd be really glad to. To reach this point, two specific studies were critical. The first was with IO2—our oral psilocybin—used in a Phase 2 study with the University of Florida, enrolling 26 binge eating disorder patients. The data was really great. All patients reduced their binge eating episodes by 80% versus the pre-dose period, and they also saw an 80% reduction in their sense of loss of control. These are the two biggest endpoints in binge eating disorder.
What’s incredible is that it didn’t matter whether patients had daily or weekly episodes; they all experienced an 80% reduction after a single dose. That response lasted over 60 days. We also observed benefits with comorbidities—depression reduced by 45%, and anxiety by 60% over 14 weeks.
The second study involved TRP-8803, our proprietary infused psilocybin. It was tested in the second half of last year and showed that all participants reached a psychedelic state in under 15 minutes, maintaining it over a two-hour period. It was well tolerated and safe, with no dose adjustments needed—even for obese participants.
Now, in partnership with Swinburne University, we’re launching a new trial: a world first. We’ll administer TRP-8803 via infusion to patients with binge eating disorder. It’s never been done before. This 12-patient study will be led by Professor Susan Rossell and aims to assess safety and the effects of TRP-8803 on binge eating frequency, sense of control, food and alcohol intake, BMI, waist circumference, and other indicators, including anxiety and depression. Outcomes will be measured four weeks after the second dose.
Targeting BED
Proactive: You cover a range of disorders—so why focus on binge eating disorder with this trial?
Jason Carroll: Good question. Tryptamine decided to target binge eating disorder for a few key reasons. It's the most common eating disorder in the US and the second most common here in Australia. It's associated with severe, longstanding health issues and a lot of unmet need. Most therapies don’t work beyond cognitive behavioural therapy.
BED also carries significant comorbidities—depression, anxiety, PTSD, alcohol use disorder, and sleep disorders. These conditions make BED life-threatening for some. Our Phase 2 data with IO2 gave us high confidence, and while we’re confident in all our programs, this is the one where we believe we can make the most impact early. We also want to show both investors and the public how effective this treatment could be. So it's a very exciting move for us.
What's next?
Proactive: Plenty going on with this trial, but you’ve always got something happening in the background. What can investors expect in the coming months?
Jason Carroll: Absolutely. In the first half of this year, and into the second, we’ve got a lot of additional data coming. The IBS study with Massachusetts General Hospital is closing out soon—they’re currently dosing patients with IO2. They’ve dosed six and have five more to go. We expect completion in Q2 and a final clinical study report in the second half.
We’ll also have study reports from our US binge eating disorder and fibromyalgia studies. The beauty of our programs is that investors don’t have to wait years for data. Many patients report changes within days or weeks. We’ll have ongoing data in the second half of the year and will also update on new programs planned for 2025. Exciting times ahead.
Proactive: Plenty to look forward to. Jason, love what you’re doing and look forward to speaking again.
Jason Carroll: Thanks so much, Jonathan. Appreciate it.