Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has the data from its recent low-cost Phase 1b study into an obese human population using its flagship asset TRP-8803, a proprietary psilocin-based, intravenously (IV) infused formulation with neuroplastic benefits.
Important step in clinical pathway
“The successful completion of our Phase 1b study into an obese subject population marks another important step in the company’s clinical development pathway for TRP-8803,” said CEO Jason Carroll.
“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.”
The open-label study was conducted between November 21 and 28 at CMAX Clinical Research in Adelaide using TRP-8803, assessing differences in pharmacokinetic parameters in obese participants compared with previously studied non-obese subjects.
The results gleaned strengthen the company’s data suite in pursuit of active patient studies.
Accordingly, Tryp is now planning for Phase 2 clinical trials into specific indications, including Binge Eating Disorder.
Onset achieved in under 20 minutes
The study found the pharmacokinetic parameters of TRP-8803 in healthy obese volunteers was consistent with non-obese healthy human volunteers.
Three subjects were treated 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 at the same mid-range dosage used in the company’s previously completed Phase 1b study into non-obese human volunteers.
All obese subjects achieved onset of the psychedelic state in under 20 minutes, with the data confirming that the previously observed optimal range of psilocin blood levels are highly similar in non-obese and obese individuals.
Infusion means greater dosage control
Obese volunteers infused with TRP-8803 achieved and maintained controlled psilocin blood levels within the putative therapeutic zone, which had not been the case for previously reported oral dosing studies.
This means the infusion has an ability to deliver considerably greater dosage control and avoid the high variability of oral psilocybin dosing, which in turn may maximise neuroplastic treatment benefits for patients with neuropsychiatric conditions.
The data provides for further optimisation of psilocin dosing to achieve the desired pharmacokinetic profiles in future Phase 2 patient trials using TRP-8803.
Tryp is committed to exploring the optimal pharmacokinetic profile of TRP-8803 using this low-cost study and the valuable human data it reveals will define a pathway to proceed to Phase 2 clinical studies.
The advanced trials are planned for 2025 and will include examining solutions to Binge Eating Disorder.
Neuroplasticity can reduce symptoms
TRP-8803 is commercially scalable and has potential neuroplastic benefits.
Pharmaceuticals that achieve a change in neuroplasticity are known to cause adaptive structural and functional changes within the brain that are thought to be responsible for clinical improvements across a range of indications.
The intravenously administered TRP-8803 has several advantages over oral psilocybin dosing including a quick onset – under 20 minutes – and precise control of the depth and duration to the psychedelic state in a commercially feasible timeframe.
The decision to conduct the study followed exceptional results from the company’s healthy human volunteer study, as well as Tryp’s Phase 2a Binge Eating Study in partnership with the University of Florida, which used oral psilocybin, TRP-8802.
That study pointed to an average reduction in binge eating episodes of over 80% in patients compared with the baseline, in addition to commensurate reductions in anxiety and depression and a durability of effect up to 60 days.
Clinically backed solution
“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,” Carroll said.
“We are 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 Tryp’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.”