Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has dosed all participants in its Healthy Human Volunteer Study (Phase 1b) undertaken at CMAX Clinical Research in Adelaide.
As part of the Phase 1b study, TRP-8803 — a proprietary formulation of IV-infused psilocin — was successfully administered for a period of up to 150 minutes to 11 participants across three cohorts, each of whom was safely discharged following treatment and dosing follow-up.
The trial was an open-label design, undertaken with therapist support, and was designed to refine and optimise dose and infusion rates for IV-infused psilocin, or TRP-8803, in volunteers to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile to determine TRP-8803’s ideal safety profile for therapeutic use in patients
This Phase 1b trial marks an important milestone for TYP, providing specific insights into the upper and lower blood concentration limits of psilocin needed to gain and maintain the ideal patient therapeutic zone of circulating psilocin to achieve optimal patient response. The results will be utilised for patent applications, which the company expects to lodge in the near term.
Specifically, completion of the study and positive results will underpin future trials utilising TRP-8803 in key indications including binge eating disorder (BED) and fibromyalgia syndrome (FMS).
A “pivotal” study
Tryptamine CEO Jason Carroll said: “To have completed this Phase 1b clinical study in just two months and have had all 11 participants discharged following their IV-infusion is a major achievement for Tryp.
“This study was pivotal for the company, as it allowed us to learn and refine the ideal infusion dose level for TRP-8803 to ensure that circulating blood concentrations of psilocin remain consistent and within the proposed therapeutic zone in participants over a two-and-a-half-hour period.
“Further, the results will continue to build on our thesis that Tryp’s innovative and proprietary IV-infusion may overcome the significant problems associated with oral dosing of a psychedelic pharmaceutical compound.
“Defining therapeutic, reproducible blood level results in patients is one of the key pillars to the company’s strategy and we look forward to reviewing results and providing these to shareholders in the coming weeks.”
A Safety Review Council review of all data is now underway to determine if results meet the proposed safety criteria of the trial. The company will provide further updates once available.
Phase 2a trials successful
The company’s upcoming TRP-8803 clinical trials have been significantly de-risked via the successful completion of Phase 2a trials utilising TRP-8802 (oral psilocybin).
The Phase 2a trial with the University of Florida highlighted an average reduction in binge eating episodes of above 80% in patients with BED and reduced both anxiety and depression.
Meanwhile, the Phase 2a trial with the University of Michigan in fibromyalgia delivered a clinically meaningful reduction in pain, pain interference, pain anxiety, brain-fog and fatigue in patients.
Carroll added that the Phase 1b “results will allow us to advance additional clinical trials using TRP-8803, in close collaboration with our partners and the Therapeutic Goods Administration (TGA) focusing squarely on specific clinical indications of high unmet patient need.
“We have considerably de-risked our program through our Phase 2a trial program into Binge Eating Disorder and Fibromyalgia with two of the finest teaching hospitals in the US and are very excited to replicate or improve on these results with our proprietary IV-infusion technology.”