Tryptamine’s psilocin infusion study reveals solid results in obese

Objectives of Tryptamine’s phase 1b study extension of lead asset TRP-8803 in healthy obese volunteers have been met
Study aimed to determine if any differences in pharmacokinetic parameters compared to previously studied non-obese subjects
Data confirmed previously observed optimal range of psilocin blood levels were highly similar in non-obese and obese individuals.

Special Report: Clinical-stage biotech Tryptamine Therapeutics (ASX:TYP) has reported that the phase 1b trial of its novel IV-infused psilocin formulation TRP-8803 in healthy obese volunteers has achieved its objectives and is consistent with non-obese healthy human volunteers.

This open-label study was conducted at CMAX Clinical Research in Adelaide to determine if pharmacokinetic (PK) parameters differed compared to previously studied non-obese subjects.

The week-long study, which completed on November 28, treated three subjects with TRP-8803 over a period of 140 minutes each.

Participants were administered an initial loading dose of TRP-8803, followed by a maintenance dose.

Tryptamine said subjects were administered the same mid-range dosage used in the company’s previously completed phase 1b study into healthy human volunteers.

The company said each subject progressed through the treatment well and were respectively discharged shortly after dosage completion.

Based on a review of the study results, all obese subjects achieved onset of the psychedelic state in under 20 minutes.

The company said the data confirmed previously observed optimal range of psilocin blood levels were highly similar in non-obese and obese individuals.

Furthermore, obese volunteers infused with TRP-8803 achieved and maintained controlled psilocin blood levels within the putative therapeutic zone.

Tryptamine noted that previously reported oral dosing studies were not able to achieve this outcome.

“This highlights the infusion’s ability to deliver considerably greater dosage control and avoid the high variability of oral psilocybin dosing which may maximise neuroplastic treatment benefits for patients with neuropsychiatric conditions,” the company noted.

Source: Tryptamine Therapeutics

Building on previous study

The study builds on the company’s successful healthy volunteer study and its phase 2a Binge Eating Study in collaboration with the University of Florida, which used its oral psilocybin formulation TRP-8802.

The company said this earlier study highlighted an average reduction in binge eating episodes of over 80%, along with commensurate reductions in anxiety and depression and a durability of effect up to 60 days.

CEO Jason Carroll said the successful completion of its phase 1b study into an obese subject population marks another important step in the company’s clinical development pathway for TRP-8803.

“In particular, the application of the treatment for a cohort of obese subjects has allowed us to obtain very valuable data on accurate dosing levels across diverse patient groups,” he said.

“The results from this study extension clearly demonstrate that the TRP-8803 dose selected for obese subjects will achieve similar pharmacokinetics to the non-obese population.

He said Tryptamine was confident of the infusion being effective for an obese population without the need for weight-based dosing regimens.

“The study met the required safety standard, as well as delivery of consistent and accurate psilocin blood levels within the targeted zone when compared to any published results from literature for oral psilocybin dosing regimens.

“The results further support Tryptamine’s stated objective to develop a clinically backed solution for high-precision neuroplastic treatments to achieve improved health outcomes.

“The extended phase 1b results for TRP-8803 will be incorporated into a comprehensive planning program for phase 2 clinical studies, which are scheduled to commence next year.”

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

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