Tryptamine Therapeutics (ASX:TYP) completes pivotal Phase 1b trial for psilocin-based therapy

Tryptamine Therapeutics (ASX:TYP), a clinical-stage biotechnology company, has successfully completed its Phase 1b Healthy Human Volunteer Study for TRP-8803, an innovative IV-infused psilocin formulation.

This study represents a significant advancement in the company’s efforts to develop new treatments for conditions with limited effective therapies.

The trial, conducted at CMAX Clinical Research in Adelaide, involved 11 participants who received the TRP-8803 infusion over 150 minutes.

The primary goal of the study was to refine dosing and infusion rates to achieve optimal blood levels of psilocin, ensuring the safety and efficacy of the treatment.

Key Developments:

• Successful Trial Completion: All participants safely completed the study and were discharged following post-dosing monitoring, marking a crucial step forward in the development of TRP-8803.
• Dose Refinement: The study focused on optimising the infusion process to maintain precise blood concentrations of psilocin, crucial for the formulation’s therapeutic potential.
• Safety Review: A thorough safety evaluation is currently underway, with full results expected to be released soon. This review will determine if the study has met its safety objectives.
• Future Clinical Trials: The successful completion of this Phase 1b study lays a strong foundation for upcoming clinical trials targeting Binge Eating Disorder (BED) and Fibromyalgia Syndrome (FMS), conditions that currently lack effective treatments.
• Building on Previous Success: Earlier trials using TRP-8802, an oral psilocybin formulation, have shown promising results, including a significant reduction in binge eating episodes and notable improvements in fibromyalgia symptoms.

Jason Carroll, CEO of Tryptamine Therapeutics, described the trial’s success as a major milestone for the company. “Completing this study within two months and having all participants safely discharged is a tremendous achievement. This trial was critical in helping us determine the ideal infusion dose level for TRP-8803, ensuring consistent and therapeutic blood concentrations of psilocin. The results reinforce our confidence in the potential of our IV-infusion technology to address challenges associated with oral psychedelic treatments.”

Carroll also highlighted the de-risked nature of future trials, stating, “Our Phase 2a trials in Binge Eating Disorder and Fibromyalgia, conducted with top U.S. teaching hospitals, have laid a solid foundation. We are eager to see how TRP-8803 performs in upcoming studies, which we believe could significantly improve treatment outcomes for these conditions.”

The completion of this trial not only advances Tryptamine Therapeutics’ clinical pipeline but also positions the company at the forefront of psychedelic drug development.

The insights gained will be crucial as the company prepares for larger-scale trials and potential commercial applications.

As the safety review continues, the industry and investors alike will be watching closely for the final results, which could have far-reaching implications for the future of psychedelic therapy.

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