Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has clearance from the Safety Review Council (SRC) for its flagship proprietary intravenous (IV)-infused psilocin formulation TRP-8803, which has been deemed generally safe and well-tolerated in a Phase 1b study.
Setting the stage for further clinical exploration
This is a milestone in the product’s clinical journey and provides a strong foundation for the further progress of the company’s broader clinical program.
The Phase 1b study, conducted with healthy volunteers, sought to evaluate the safety of varying doses of TRP-8803.
The IV-infused psilocin achieved plasma levels associated with therapeutic benefits seen in oral psilocybin treatments.
The study, held at CMAX Clinical Research in Adelaide, kicked off in June 2024 and was overseen by the SRC to ensure safety and inform dose optimisation for future patient trials.
Eleven participants were administered TRP-8803 for up to 150 minutes in an open-label study design.
The purpose of the trial was to refine and optimise the infusion rate and dosing to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile.
These results set the stage for further clinical exploration of TRP-8803 in therapeutic settings.
Reduction in binge eating
Building on the success of the trial, Tryptamine will now shift its focus to the next phase of clinical development, including the design of Phase 2 trials.
The company’s strategy is informed by recent successes in Phase 2a trials of its oral psilocybin formulation, TRP-8802, which demonstrated considerable benefits in treating Binge Eating Disorder and Fibromyalgia.
The Phase 2a Binge Eating Disorder trial, conducted in partnership with the University of Florida, saw an average reduction in binge eating episodes of over 80%.
In a separate Phase 2a trial at the University of Michigan, TRP-8802 demonstrated clinically meaningful reductions in pain, anxiety and fatigue in patients with Fibromyalgia.
Following these promising outcomes, the company plans to integrate its findings from TRP-8802 into the continued development of TRP-8803.
The novel IV formulation offers potential advantages over oral psilocybin, including faster onset of effects, more controlled psychedelic experiences and a shorter intervention duration, which may make the asset more suitable for widespread clinical use.
Safety clearance from the SRC is a pivotal step in the company’s ongoing efforts to develop precision treatments using psilocin.
What’s next?
Tryptamine says it’s committed to advancing its clinical pipeline and will continue working towards regulatory engagement and the highest standards of quality control in its product development.
Further updates on the clinical pathway for TRP-8803, including Phase 2 study plans, are expected in the coming months.