Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has successfully administered a dose of TRP-8803 to the first participant from an obese population, completing the first treatment over 140 minutes.
TRP-8803 is a psilocin-based IV-infusion with potential neuroplastic benefits, which are known to cause adaptive structural and functional changes within the brain that are thought to be responsible for clinical improvements.
The open-label study at CMAX Clinical Research in Adelaide will use TRP-8803 to determine if there are any differences in pharmacokinetic parameters compared to previously studied non-obese patients.
The study will add three obese participants to the company’s ongoing Phase 1 study protocol.
Two additional study applicants will receive dosing over the coming weeks, and Tryptamine expects the interim results from these participants to be available this year.
Capital efficient, valuable data
“We are very excited to have commenced this trial focused on an obese subject population,” Tryptamine Therapeutics CEO Jason Carroll said.
“The initiative is very capital efficient and will provide the company with valuable data to further refine TRP-8803 dosing rates across a broader cross section of the population, while also building on our comprehensive dataset.
“The first patient dosing follows exceptional and positive results from an initial three patient cohorts, which have determined TRP-8803’s safety, optimal dose and infusion rates and highlighted TRP-8803’s ability to achieve improved health outcomes at scale.
“This dataset will be used to inform the company’s Phase 2 trial planning, which will explore the application of TRP8803 across specific indications.
“The board and management are assessing a number of opportunities in relation to Phase 2 trials for TRP-8803 and look forward to providing further updates as developments materialise.”
TYP says its TRP-8803 formulation has several advantages over oral psilocybin dosing, including faster onset (under 20 minutes) with precise control of the depth and duration to the psychedelic state in a commercially feasible timeframe.
The company believes this additional obesity-focused element of the trail will provide valuable, cost-effective data to support dose selection for future Phase 2 trials into specific weight-related indications including Binge Eating Disorder.