Tryptamine Therapeutics Advances Psilocin-Based IV Infusion To Phase 2 Clinical Trials

Tryptamine Therapeutics Ltd TYPTF has announced that its lead asset, TRP-8803, a psilocin-based IV infusion, will progress to Phase 2 clinical trials following a successful Phase 1b study. TRP-8803 demonstrated significant advantages over oral psilocybin, including rapid onset, precise control of the psychedelic state and the ability to halt treatment if adverse events occur, enhancing patient safety.

Phase 1b Achievements

TRP-8803 was well-tolerated across all tested doses—low, mid and high—demonstrating its safety profile. The study identified optimal doses and infusion rates that maintained psilocin blood levels within the therapeutic range. Additionally, TRP-8803 achieved steady and controlled blood levels, outperforming oral psilocybin formulations in terms of consistency.

Participants experienced a rapid onset of the psychedelic state, much faster than the typical one- to two-hour delay with oral psilocybin. "To have achieved these positive results from our Phase 1b for TRP-8803 study so quickly has exceeded all expectations," said Tryptamine CEO Jason Carroll.

Path To Phase 2

Armed with a robust proprietary dataset, Tryptamine is preparing to advance TRP-8803 to active patient studies. Phase 2 trials will target specific therapeutic indications, with planning already underway. Carroll highlighted the importance of these findings, stating, “Tryp has now established the strong foundations essential to advance our world-first trials for IV-infused psilocin to the highest standards of safety, quality and integrity.”

TRP-8803: A Transformative Approach

TRP-8803 offers multiple advantages over traditional oral psilocybin. It provides faster onset, precise control over treatment duration and reversibility, enabling clinicians to halt therapy immediately if necessary. These features make the treatment safer and more commercially viable while reducing the overall duration of therapy. By promoting neuroplasticity, TRP-8803 aims to drive adaptive structural and functional changes in the brain, solidifying Tryptamine's position at the forefront of psychedelic medical innovation.

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