‘Significant derisking catalyst’: Tryptamine’s world-first IV psilocin drug found safe

Tryptamine’s IV-infused psilocin formulation TRP-8803 found to be generally safe and well tolerated in a Phase 1b study.

TYP has reported positive results from its Phase 1B study of its IV-infused psilocin formulation. Pic: Getty Images.

• Tryptamine’s IV-infused psilocin formulation TRP-8803 ‘generally safe and well tolerated’

• Findings are from Safety Review Council into Phase 1b study of TRP-8803

• Result provides confidence to advance additional Phase 2 TRP-8803 clinical trials

 

Special Report: Tryptamine Therapeutics has achieved a key milestone in development of its innovative IV-infused psilocin formulation TRP-8803, which was found to be generally safe and well tolerated in healthy volunteer participants dosed in a clinical setting.

Tryptamine Therapeutics (ASX:TYP) has announced the Safety Review Council (SRC) for its ongoing Phase 1b has deemed that TRP-8803 was generally safe and well-tolerated in healthy volunteers at doses that achieve plasma levels of psilocin associated with beneficial effects in various patient populations treated with oral psilocybin.

The safety finding for TRP-8803 follows completion of the company’s Phase 1b study in healthy volunteers at CMAX Clinical Research in Adelaide in August.

The open-label study, which commenced in June 2024, was conducted with therapist support and TYP said it was believed to be the only time that an IV-infused psilocin solution had been used anywhere in the world.

The SRC provided oversight to review safety data and recommend any necessary modifications to the trial protocol, including guidance on the dose range of TRP-8803 for use in patient trials.

During the study, 11 healthy volunteer participants received TRP-8803 via IV-infusion at varying levels for up to 150 minutes.

The study aimed to refine and optimise the dose and infusion rate of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile.

Addressing current limitations of psilocybin

TRP-8803 is an IV-infusion of psilocin, which works to address many of the current limitations associated with orally administered psilocybin used by most competitors in the field.

Like all oral medications, an oral capsule of psilocybin must go through the liver, which is known as first pass metabolism.

After being metabolised by the liver, psilocin – the active metabolite of psilocybin – can have different effects on people, depending on how effectively their liver works.

For patients to all get the same dose TYP said you need to do it in a way which is IV-directed and fast acting.

TYP said other advantages of IV-infusion was it required less medical supervision of the patient and its reversibility, where the IV can be slowed down or turned off.

Confidence to move into Phase 2 trials

TYP said the Phase 1b findings represented a major milestone and provided the company with exceptional confidence to advance into additional Phase 2 clinical trials for TRP-8803.

The company’s clinical pathway also includes an ongoing review of previous trials using TRP-8802 (oral psilocybin), which have demonstrated clinically meaningful results in Binge Eating Disorder and Fibromyalgia.

TYP has previously achieved positive results from two Phase 2a studies, including one with the University of Florida, focused on Binge Eating Disorder which showed an average reduction in binge eating episodes of more than 80%.

Another trial with the University of Michigan in Fibromyalgia demonstrated clinically meaningful reductions in pain, pain interference, pain anxiety, brain fog, and fatigue in patients.

Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain, fatigue, and other symptoms such as sleep disturbances and cognitive difficulties.

The trial involved patients taking TRP-8802, an oral psilocybin formulation, along with psychotherapy.

‘Significant derisking catalyst’

CEO Jason Carroll said the safety clearance provided by the SRC for TRP-8803 was a major milestone for the company.

“It further validates TYP’s approach to drug development and serves as a significant derisking catalyst moving forward,” he said.

“Our focus now is on finalising the results of the Phase 1b study, allowing us to better understand the benefits TRP-8803 may provide to patients, refine its pharmacokinetic profile, and prepare for a Phase 2 patient study for its first specific indication.”

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.

Originally published as ‘Significant derisking catalyst’: Tryptamine’s world-first IV psilocin drug found safe