Tryptamine completes Phase 1b trial lead program TRP-8803. Pic: Getty Images.
Health & Biotech
Special Report: Clinical-stage biotech Tryptamine Therapeutics has achieved a key milestone, successfully completing the Phase 1b study of its lead program TRP-8803, an innovative and scalable IV-infusion of psilocin.
Tryptamine Therapeutics (ASX:TYP) said all participant dosing in its healthy human volunteer study undertaken at CMAX Clinical Research in Adelaide has been completed.
The open-label designed trial was undertaken with therapist support and the company said it is believed to be the only time that an IV-infused psilocin solution has been used anywhere in the world.
All 11 participants across three cohorts were administered TRP-8803 in varying doses over 150 minutes and discharged after dosage follow up was completed as part of the Phase 1B open-label study.
The study was designed to refine and optimise dosing and infusion rates for TRP-8803 in volunteers to achieve precise blood levels of psilocin and gain an acceptable pharmacokinetic profile and determine ideal safety profile for therapeutic use in patients.
The company said the Phase 1B trial also would form the basis for new patent applications, which are expected to be lodged in the near-term.
TYP says a Safety Review Council of all data is now underway which will determine if the safety criteria of the trial have been met. The company said it will provide further updates on results over coming weeks as they become known.
Completion of TYP’s Phase 1b TRP-8803 study follows positive results obtained from two Phase 2a trials of the company’s oral psilocybin drug, TRP-8802, in the US.
A University of Florida Phase 2a study of TRP-8802 focused on binge eating disorder delivered an average reduction in binge eating episodes of over 80%.
A Phase 2a trial of TRP-8802 with the University of Michigan in Fibromyalgia delivered a clinically meaningful reduction in pain, pain interference, pain anxiety, brain-fog and fatigue in patients.
TYP is also undertaking a Phase 2a clinical trial of TRP-8802 investigating the treatment of irritable bowel syndrome (IBS) with Massachusetts General Hospital in the US.
Where a positive clinical response is demonstrated, Carroll says subsequent studies are expected to use TRP-8803 (IV-infused psilocin).
TRP-8803 is an IV-infusion of psilocin addressing 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 a person with a slow metabolism their brain may get more psilocin than they need and someone with a fast metabolism may get more than required.
TYP said for patients to all get the same dose you need to do it in a way which is IV-directed and fast acting.
Other advantages of IV-infusion is it requires less medical supervision of the patient and its reversibility, where the IV can be slowed down or turned off.
CEO Jason Carroll said to have completed the Phase 1b clinical study in just two months and have had all 11 participants discharged following their IV-infusion is a major achievement for the company.
“The study was pivotal for the company, as it allowed us to learn and refine the ideal infusion dose level for TRP-8803 to ensure that circulating blood concentrations of psilocin remain consistent and within the proposed therapeutic zone in participants over a two-and-a-half-hour period,” he said.
“Further, the results will continue to build on our thesis that Tryp’s innovative and proprietary IV-infusion may overcome the significant problems associated with oral dosing of a psychedelic pharmaceutical compound.”
Carroll said defining therapeutic, reproducible blood level results in patients is one of the key pillars to the company’s strategy.
“These results will then allow us to advance additional clinical trials using TRP-8803, in close collaboration with our partners and the Therapeutic Goods Administration focusing squarely on specific clinical indications of high unmet patient need,” he said.
“We have considerably de-risked our program through our Phase 2a trial program into Binge Eating Disorder and Fibromyalgia with two of the finest teaching hospitals in the US and are very excited to replicate 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 publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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