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Successful Maiden Dosing of TRP-8803 (IV-Infused Psilocin) Completed in Global First

Tryptamine Therapeutics Limited (‘Tryp’ or the ‘Company’) (ASX: TYP), a clinical-stage biotechnology company focused on the development of an innovative and scalable intravenous-infused psilocin formulation which may be used in conjunction with psychotherapy to address significant unmet medical needs, is pleased to advise that it has successfully and safely completed the world’s first participant dosing using TRP-8803 (IV-infused psilocin) in a patient in Adelaide, South Australia.

  • Completion of first participant dosing for TRP-8803 (IV-infused psilocin) Healthy Human Volunteer Study – Trial being undertaken alongside CMAX Clinical Research in Adelaide and marks a world-first in psychedelic treatment
  • Study aims to refine and optimise dosing and infusion rates of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetics profile in up to 12 participants to determine TRP-8803’s safety in humans – results will inform TYP’s Phase 2a patient study pipeline
  • Participant successfully underwent psilocin infusion over 140 minutes, progressed well through treatment and was discharged on completion
  • TRP-8803’s potential advantages include a significant reduction in onset of the psychedelic state, more precise control of the depth and duration of the experience and a reduction in the duration of the intervention to a commercially feasible timeframe
  • Successful first participant dosing reinforces management confidence in TRP-8803 and its potential
  • Trial expected to completed during Q3 2024 with results to be reported thereafter – Positive results will provide Tryp with the potential to advance its clinical trial pipeline across multiple conditions
The participant was administered TRP-8803 (IV-infused psilocin) as part of the Company’s planned Healthy Human Volunteer Study, which is being undertaken by CMAX Clinical Research in Adelaide. The trial is an open-label design, undertaken with therapist support and aims to refine and optimise dosing and infusion rates of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetics profile in up to 12 participants and to determine its safety prior to additional clinical studies which will be focused on particular need states.

Tryp advises that the participant was provided with TRP-8803, the Company’s innovative IV-infused psilocin solution on Friday, 28 June for approximately 140 minutes and progressed through the treatment safely. The participant was discharged after dosing follow-up was completed.

TRP-8803, Tryp’s lead program alleviates a number of significant shortcomings of oral psilocybin therapy. Potential advantages of the Company’s IV-infused psilocin solution include a significant reduction in the time to onset of the psychedelic state, more precise control of the depth and duration of the psychedelic experience and a reduction in the overall duration of the intervention to a commercially feasible timeframe.

The Company will continue to work alongside CMAX Clinical Research to deliver the solution to the additional participants over the coming weeks. Tryp anticipates to receive interim results from the trial during Q3 2024, which will provide a greater understanding of the solution’s potential in humans.

Management commentary:

Tryp Chief Executive Officer, Mr. Jason Carroll said: “We are very pleased to have completed the world’s first TRP- 8803 treatment in a patient in Adelaide. Pleasingly, the maiden participant was delivered the infusion safely and was discharged on treatment conclusion, which provides management with confidence of TRP-8803 and the completion of this Healthy Human Volunteer Study.

“The trial, which being undertaken alongside CMAX is an incredibly important initiative for Tryp, as it will provide us with data highlighting TRP-8803’s safety in humans at escalating doses. This will form the basis of the Company’s clinical trial pipeline into other indications and ultimately our regulatory engagement.

“The Company expects that up to 12 participants to undertake infusion over the coming weeks and we look forward to provide further updates as the trial advances.”

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