Tryptamine Therapeutics achieves milestone of world’s first IV-infused psilocin dosing

Recently-listed biotech company Tryptamine Therapeutics (ASX: TYP) has successfully completed the world’s first dosing of a patient with intravenous (IV)-infused psilocin (TRP-8803) in South Australia.

The participant dosing of TRP-8803 is part of the company’s planned healthy human volunteer study at CMAX Clinical Research in Adelaide.

Tryptamine is developing a scalable IV-infused psilocin formulation which may be used in conjunction with psychotherapy to address significant unmet medical needs.

Optimal dosage

Chief executive officer Jason Carroll said the trial aims to refine and optimise the dosing and infusion rates of TRP-8803.

He said this will help achieve precise blood levels of psilocin with an acceptable pharmacokinetics profile to determine TRP-8803’s safety prior to additional clinical studies.

“Pleasingly, the maiden participant was delivered the infusion safely and was discharged on treatment conclusion, which provides management with confidence of TRP-8803 and the completion of this healthy human volunteer study,” Mr Carroll said.

“This will form the basis of the company’s clinical trial pipeline into other indications and ultimately our regulatory engagement.”

“The company expects that up to 12 participants to undertake infusion over the coming weeks and we look forward to provide further updates as the trial advances.”

Safe progress

The initial participant was provided with TRP-8803 for approximately 140 minutes and progressed through the treatment safely before being discharged after dosing follow-up was completed.

The company believes TRP-8803 alleviates a number of significant shortcomings of oral psilocybin therapy, with the IV-infused psilocin solution providing a significant reduction in the time to onset of the psychedelic state.

It also allows for more precise control of the depth and duration of the psychedelic experience and a reduction in the overall duration of the intervention to a commercially-feasible timeframe.

Tryptamine expects to receive interim results from the trial during Q3 2024.

Treating eating disorders

Meanwhile, the company has completed a Phase 2a clinical trial using its other candidate TRP-8802 for the treatment of binge eating disorders at the University of Florida.

That trial demonstrated an average reduction of greater than 80% in bingeing episodes.

Additionally, the company is dosing patients in a Phase 2a clinical trial in collaboration with University of Michigan for the treatment of fibromyalgia.

It is also preparing to initiate a Phase 2a clinical trial in collaboration with Harvard University and Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel syndrome.

Where a positive clinical response to TRP-8802 is demonstrated in any of these trials, subsequent studies are expected to utilise TRP-8803’s potential to further improve efficacy, safety and patient experience.

ASX listing

Tryptamine listed in late May following the completion of a binding plan of arrangement for Exopharm (ASX: EX1) to acquire 100% of the issued capital in Canadian-listed Tryp Therapeutics.

Under the arrangement, Exopharm completed a public offer of shares under a full form prospectus via the issuance of 325,000,000 fully paid ordinary shares at an issue price of $0.02 per share to raise $6,500,000.