The recently completed Phase 1b study of Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) successfully met all key objectives, paving the way to advance to Phase 2 clinical trials of TRP-8803 — an innovative and scalable psilocin-based IV-infusion with potential neuroplastic benefits.
TRP-8803 has multiple advantages over oral psilocybin dosing including faster onset (under 20 minutes) with precise control of the depth and duration to the psychedelic state in a commercially feasible timeframe.
The company highlights that all trial participants achieved rapid onset of the psychedelic state, compared to one to two hours observed in oral psilocybin trials.
“To have achieved these positive results from our Phase 1b for TRP8803 study so quickly has exceeded all expectations and allows the company to advance its clinical trial pipeline immediately,” Tryptamine CEO Jason Carroll said.
TRP-8803 achieved steady and controlled blood levels of psilocin consistently within the therapeutic zone.
All objectives of the Phase 1b study were met including:
- TRP-8803 safe at low, mid and upper dose levels;
- Optimal doses and infusion rates of psilocin that achieved target psilocin blood levels were identified; and
- Greater control of psilocin blood levels achieved compared to oral psilocybin formulations.
“We are very pleased to have achieved all of the key objectives from the Phase 1b, including safety and optimised blood psilocin levels, all of which further highlight the potential of the treatment to achieve improved health outcomes at scale,” Carroll said.
“More broadly, the company’s goal at the outset of the Phase 1b trial program was to build a comprehensive dataset that could establish a sound framework for the next phase of our planned clinical development pathway.”
Phase 2 trials ahead
The company now has all data necessary to proceed to active patient studies and planning for additional clinical trials using TRP-8803 for specific therapeutic indications is underway.
“The completion of the study has provided Tryp with a valuable proprietary data set that will inform the design of extensive Phase 2 trials, along with the application of TRP-8803 across the company’s broader trial program,” added Carroll.
“From a research perspective, Tryp has now established the strong foundations essential to advance our world-first trials for IV-infused psilocin to the highest standards of safety, quality and integrity.
“This diligent approach is what is required to unlock the potential that is inherent in clinically backed psychedelic medicine solutions.
“We look forward with excitement to ongoing collaboration with our best-in-class research partners and bringing our investors along for the journey in this rapidly emerging field.”
Phase 1b background
The new findings follow completion of the Phase 1b study, as well as determination from the Safety Review Council that TRP-8803 was generally safe and well-tolerated in healthy volunteers.
During the study, 11 participants were administered TRP-8803 via IV-infusion at varying dose levels for up to 150 minutes. It was designed to refine and optimise the dose and infusion rate of TRP-8803 to achieve the precise, desired blood levels of psilocin with an acceptable pharmacokinetic profile.
Tryp’s lead asset TRP-8803
TRP-8803 is Tryp’s lead asset. It 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 which improve neuroplasticity are known to cause adaptive structural and functional changes within the brain.
TRP-8803 offers multiple potential benefits over oral psilocybin, including a faster time to onset with more precise control of the depth and duration of the psychedelic state, while also offering significant overall reductions in the duration of treatment to a commercially feasible timeframe.
Importantly, TRP-8803’s major advantage is inherent reversibility, allowing for treatment to be halted quickly if patients experience adverse events. This critical safety benefit cannot be achieved using oral dosing.