Tryptamin completes world’s first Phase 1b intravenous infusion trial of psilocin

• Tryptamin completes Phase 1b study of its lead program TRP-8803, an intravenous infusion of psilocin

• This is probably the first study with psilocin infusions worldwide.

• All 11 patients were administered TRP-8803 in escalating doses over 150 minutes and were discharged after follow-up.

Special report: Clinical-stage biotech company Tryptamine Therapeutics has reached an important milestone and successfully completed the Phase 1b study of its lead program TRP-8803, an innovative and scalable intravenous infusion of psilocin.

Tryptamine Therapeutics (ASX:TYP) said dosing of all participants in its study of healthy volunteers, conducted at CMAX Clinical Research in Adelaide, had been completed.

The open-label study was conducted with the assistance of a therapist and, according to the company, is believed to be the only time in the world that an intravenously administered psilocin solution has been used.

All 11 participants from three cohorts were administered TRP-8803 at varying doses over 150 minutes and were discharged after dosing follow-up was completed in the open-label Phase 1B study.

The objective of the study was to refine and optimize the dosing and infusion rates for TRP-8803 in volunteers to achieve precise psilocin blood levels, maintain an acceptable pharmacokinetic profile, and determine the ideal safety profile for therapeutic use in patients.

The company said the Phase 1B study will also form the basis for new patent applications that are expected to be filed shortly.

TYP says a safety review board of all data is currently underway to determine whether the trial's safety criteria were met. The company said it will provide further updates on the results in the coming weeks as they become known.

Study follows positive oral psilocybin trial

The completion of TYP's Phase 1b TRP-8803 trial follows positive results from two Phase 2a trials of the company's oral psilocybin drug TRP-8802 in the United States.

A Phase 2a study of TRP-8802 at the University of Florida that focused on binge eating showed an average reduction in binge eating of over 80%.

A Phase 2a study of TRP-8802 with the University of Michigan in fibromyalgia showed clinically meaningful reductions in pain, pain interference, pain anxiety, brain fog and fatigue in patients.

TYP is also conducting a Phase 2a clinical trial of TRP-8802 for the treatment of irritable bowel syndrome (IBS) with Massachusetts General Hospital in the United States.

If a positive clinical response is demonstrated, Carroll said, subsequent trials are expected to use TRP-8803 (intravenously infused psilocin).

Address current limitations of psilocybin therapy

TRP-8803 is an intravenous infusion of psilocin that addresses many of the current limitations associated with oral administration of psilocybin used by most competitors in the field.

Like all oral medications, an oral capsule of psilocybin must pass through the liver (known as first-pass metabolism).

After metabolization in the liver, psilocin, the active metabolite of psilocybin, can have different effects in people depending on how well the liver is functioning.

A person with a slow metabolism may find that their brain absorbs more psilocin than it needs, and a person with a fast metabolism may find that they get more than they need.

TYP said that in order for all patients to receive the same dose, it must be given intravenously and rapidly.

Other advantages of intravenous infusion are that it requires less medical supervision of the patient and that it is reversible because the intravenous infusion can be slowed down or turned off.

“Critical for the company”

CEO Jason Carroll said it was a great achievement for the company to have completed the Phase 1b clinical trial in just two months and to have discharged all 11 participants after their intravenous infusion.

“The study was critical for the company as it allowed us to identify and refine the ideal infusion dose for TRP-8803 to ensure that psilocin levels in participants' circulating blood remained consistent and within the proposed therapeutic range over a two-and-a-half hour period,” he said.

“In addition, the results will support our thesis that Tryp's innovative and proprietary IV infusion could overcome the significant problems associated with oral administration of a psychedelic drug.”

Carroll said establishing therapeutic, reproducible blood level results in patients is one of the key pillars of the company's strategy.

“These results will then enable us to conduct additional clinical trials with TRP-8803 in close collaboration with our partners and the Therapeutic Goods Administration, focusing entirely on specific clinical indications with high unmet patient needs,” he said.

“We have significantly de-risked our program through our Phase 2a binge eating and fibromyalgia trial program in collaboration with two of the nation’s top teaching hospitals and are very excited to be able to reproduce or improve on these results with our proprietary IV infusion technology.”

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

This article does not constitute financial product advice. You should consider seeking independent advice before making any financial decisions.

Originally published as Tryptamine Completes World's First Phase 1b IV Infusion Trial of Psilocin