Tryptamine’s world-first psilocin based IV-infusion meets key objectives in phase 1b study

Tryptamine’s phase 1b study of IV-infused psilocin meets all objectives
Lead asset TRP-8803 found safe at low, mid and upper dose levels
Planning underway to advance TRP-8803 in phase II trials

Special Report: Clinical stage biotech Tryptamine Therapeutics has achieved a major milestone in the development of its novel IV-infused psilocin formulation TRP-8803, with all objectives of the phase 1b study met.

Tryptamine Therapeutics (ASX:TYP) has provided further data from its recently completed phase 1b study utilising TRP-8803, with all key objectives met 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

With the Phase 1b study successfully meeting all key objectives, TRP-8803 can now progress to phase II clinical trials.

Ground-breaking IV-infused psilocin study

The open-label study commenced in June 2024 in healthy volunteers at CMAX Clinical Research in Adelaide and completed in August.

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.

TRP-8803, Tryp’s lead asset 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.

Benefits include a faster action time, with more precise control of the depth and duration of the participant’s psychedelic state. This promises a significantly reduced timeline to commercialisation.

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

Tryptamine said this critical safety benefit cannot be achieved using oral dosing.

In October TYP announced the Safety Review Council (SRC) had deemed that TRP-8803 was generally safe and well-tolerated.

This was at doses that achieved plasma levels of psilocin associated with beneficial effects in various patient populations treated with oral psilocybin.

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

The study 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 (PK) profile.

Robust foundation for additional phase II clinical trials

Following the review of the phase 1b study, Tryptamine has built a robust foundation for additional phase II clinical trials using TRP-8803.

During the study, participants were administered an initial loading dose of TRP-8803, followed by a maintenance dose across lower, mid, and upper strengths.

Tryptamine said all participants in the study achieved a psychedelic state in under 20 minutes.

The study also met safety benchmarks across the three escalating dose levels, with all patients achieving consistent psilocin blood levels.

Tryptamine said this data ensures optimum psilocin blood levels and a PK profile to achieve maximum neuroplastic benefit.

The IV delivery method is expected to provide considerably greater dose control, avoiding the high variability of oral psilocybin dosing.

Furthermore, the escalating dosing regimen has confirmed a strong correlation between psilocin blood levels and psychedelic intensity.

Study in obese population

Tryptamine will undertake an additional small, low-cost phase 1b study in obese subjects.

The open-label study is being undertaken at CMAX Clinical Research in Adelaide. At the mid range, the study will determine if there are any differences in PK parameters for this obese cohort.

The approved study will add three obese participants to TYP’s existing study protocol, with the first participant dosed on 21 November with two additional subjects dosed shortly thereafter.

The results are expected to provide valuable and cost-effective data to support dose selection for the phase II clinical program, aimed at treating patients with Binge Eating Disorder.

The company said the decision followed exceptional results delivered from its Phase 2a binge eating study, undertaken in collaboration with the University of Florida.

The study used TYP’s synthetic oral psilocybin TRP-8802, in conjunction with psychotherapy.

Following TRP-8802 administration, patients achieved:

An average reduction in binge eating episodes of over 80% compared with baseline
Commensurate reductions in anxiety and depression
Durability of up to 60 days

Plans to advance to phase 2 trial

Tryptamine CEO Jason Carroll said achieving positive phase 1b results so unexpectedly quickly will enable the company to swiftly advance its clinical trial pipeline.

“The completion of the study has provided Tryptamine with valuable proprietary data that will inform the design of extensive phase 2 trials, along with the application of TRP-8803 across the company’s broader trial program,” he said.

Carroll said Tryptamine had established strong research foundations to advance its world-first trials 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,” he said.

“We look forward to ongoing collaboration with our best-in-class research partners and bringing our investors along for the journey in this rapidly emerging field.”

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.