Tryptamine completes psilocin-based IV-infusion study in obese subjects

Three participants were safely administered TYP’s novel IV-infused psilocin formulation TRP-8803 in phase 1b study into an obese population
Undertaken at CMAX clinical research in Adelaide the study aims to validate TRP-8803 safety and dosing rates in obese participants
TRP-8803 is an innovative, clinically scalable psilocin-based IV-infusion with potential neuroplastic benefits

Special Report: Clinical-stage biotech Tryptamine Therapeutics (ASX:TYP) has successfully and safely completed obese-subject dosing in its Phase 1b study of its novel IV-infused psilocin formulation TRP-8803.

The open-label study was undertaken at CMAX Clinical Research in Adelaide to determine if there were any differences in pharmacokinetic parameters of Tryptamine’s lead asset TRP-8803 compared to previously studied non-obese subjects.

The trial started on 21 November and ran for a week. It treated three subjects with TRP-8803 over a period of 140 minutes each.

Tryptamine said each subject progressed through the treatment well and was safely discharged shortly after study completion.

Results from the study are anticipated to be received before the end of 2024 and will support the potential application of TRP-8803 to achieve improved health outcomes in obese study participants.

The results will provide additional valuable and cost-effective data to optimise dose selection for the company’s phase II clinical program using TRP-8803 in specific indications, including binge eating disorder where the company has previously seen success.

Building on phase 1b study

The study in obese subjects builds upon the open-label 1b study in healthy adults, which was also held at CMAX Clinical Research in Adelaide, completed in August, and met all key objectives.

Tryptamine said the study – conducted with therapist support – was the first and only time that an IV-infused psilocin solution had been used globally. Psilocin is the active agent of psilocybin – a psychedelic compound found in ‘magic mushrooms’.

During the study, 11 participants were administered TRP-8803 via IV-infusion at varying dose levels, for up to 150 minutes.

TRP-8803 is an innovative and scalable psilocin-based IV-infusion formulation with neuroplastic benefits.

Neuroplasticity is the ability of neural networks in the brain to change through growth and reorganisation. Treatments that improve neuroplasticity are known to cause adaptive structural and functional changes within the brain.

Potential benefits of TRP-8803 include a faster action time, with more precise control of the depth and duration of the participant’s psychedelic state.

TRP-8803’s major advantage is its reversibility, allowing for treatment to be halted quickly if patients experience adverse events.

The phase 1b study met all key objectives including:

TRP-8803 safe at low, mid, and upper dose levels
Optimal doses and infusion rates of psilocin achieved targeted psilocin blood levels
Greater control of psilocin blood levels achieved compared to oral psilocybin formulations

Tryptamine said the phase II clinical program planning was well advanced with further updates expected over the coming months.

Tested in broad patient population

CEO Jason Carroll said to have completed subject dosing over such a short timeframe was a great achievement and highlights the considerable potential for future research opportunities using TRP-8803.

“All subjects that underwent treatment did so safely and were all discharged after the administration, marking the achievement of an important early-stage clinical objective and confirming the potential of TRP-8803 to deliver improved health outcomes in a timely manner,” he said.

“We look forward to receiving the final dataset from CMAX, which will assist in our ongoing planning for phase II trials to explore the efficacy of the application over specific unmet need states with large addressable market opportunities.

“The completion of subject dosing for the phase 1b study will now allow the company to expand its proprietary dataset across a broad patient population in a timely and cost-effective manner, as we continue to diligently execute on our comprehensive clinical development pathway for TRP-8803.”

This article was developed in collaboration with Tryptamine Therapeutics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.