Tryptamine’s Clinical Milestones Highlight Risks and Rewards in Psychedelic Therapy Race

Clinical Progress Accelerates for TRP-8803

Tryptamine Therapeutics Limited (ASX: TYP) has marked a significant milestone in its clinical development pathway with the successful completion of its Phase 1b study for TRP-8803, a proprietary intravenous (IV) psilocin formulation designed to deliver controlled neuroplastic benefits. The Safety Review Council (SRC) deemed the drug safe and well-tolerated in both healthy and obese volunteers, a critical validation that paves the way for Phase 2 patient trials.

The Phase 1b trial met all key objectives, including establishing optimal dosing regimens that achieve consistent therapeutic plasma levels of psilocin. Notably, the IV infusion method demonstrated rapid reversibility of side effects, such as a transient heart rate increase, an advantage over oral psilocybin formulations which lack such precise control.

Promising Interim Data for TRP-8802 in IBS

Alongside TRP-8803, Tryptamine reported encouraging interim results from its Phase 2a trial of TRP-8802, an oral psilocybin candidate, targeting Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital. Among the initial cohort, 75% of patients experienced meaningful reductions in abdominal pain and gastrointestinal anxiety, supporting IBS as a viable indication for psilocin-based therapies.

This gut-brain axis approach leverages psilocin’s interaction with serotonin receptors, potentially addressing both neurological and gastrointestinal symptoms. The positive data from TRP-8802 will inform the design of upcoming Phase 2 trials for TRP-8803, aiming to enhance efficacy through IV delivery.

Capital Raise and Corporate Developments

To underpin its clinical ambitions, Tryptamine successfully raised $6 million through a placement of 300 million shares at $0.02 each. The raise was led by the Merchant Biotech Fund and biotech investor Dr Daniel Tillett, who also joined the board as a Non-Executive Director during the quarter. Existing shareholders and company executives participated, signaling strong confidence in the company’s strategy.

With $2.8 million cash on hand at quarter-end, plus $3.25 million in binding commitments and an expected $1.1 million R&D tax refund, the company is well-positioned to fund its Phase 2 clinical programs. The board also saw the departure of two Non-Executive Directors, Mr Peter Molloy and Mr Clarke Barlow, who were thanked for their service.

Looking Ahead

CEO Jason Carroll highlighted the company’s progress in refining TRP-8803 dosing and expanding its clinical scope, particularly emphasizing the inclusion of obese patients to broaden therapeutic applicability. The company anticipates commencing Phase 2 trials in the near term, targeting neuropsychiatric conditions and IBS symptoms with its innovative IV psilocin formulation.

Tryptamine’s dual approach, leveraging oral and IV psilocin formulations, positions it uniquely in the emerging psychedelic therapy landscape, aiming to overcome limitations of existing oral treatments through improved pharmacokinetic control and patient safety.