Clinical-stage biotechnology company Tryptamine Therapeutics (ASX: TYP) has received positive study result confirmation about its TRP-8803 (IV-infused psilocin) candidate.
Feedback from the Safety Review Council (SRC) in the company’s ongoing Healthy Human Volunteer Study ‘Phase 1b) has deemed TRP-8803 as generally safe and well-tolerated in healthy volunteers at doses that achieve plasma levels of psilocin that have been associated with beneficial effects in various patient populations treated with oral psilocybin.
This is a major milestone for the company and provides Tryp with exceptional confidence to advance additional Phase 2 clinical trials utilising the innovative and scalable IV-infusion of psilocin.
The safety finding for TRP-8803 follows the completion of the company’s Phase 1b study, which was undertaken at CMAX Clinical Research in Adelaide, South Australia.
The study commenced in June 2024 and was an open-label design, undertaken with therapist support. The oversight of the SRC was implemented to review safety data and recommend any necessary modifications to the trial protocol and, in this instance, advise on the dose range of TRP- 8803 that appears to have a favourable therapeutic index for use in patient trials.
During the study, 11 participants were administered TRP-8803 via IV-infusion at varying levels for a period of up to 150 minutes. The study is expected to refine and optimise dose and infusion rate of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile in participants.
Upon receipt of the safety ruling from the SRC, Tryp will continue to develop its proposed clinical trial pathway for TRP-8803. This will include an ongoing review of completed trials utilising TRP-8802 (oral psilocybin), which have led to clinical meaningful results in Binge Eating Disorder and Fibromyalgia.
Previously, Tryp achieved exceptional results from both a Phase 2a study alongside the University of Florida focused on Binge Eating Disorder utilising TRP-8802 which delivered an average reduction in binge eating episodes of over 80%, and a Phase 2a trial with the University of Michigan in Fibromyalgia that delivered a clinically meaningful reduction in pain, pain interference, pain anxiety, brain-fog and fatigue in patients.
“The safety clearance provided by the SRC on TRP-8803 is a major milestone for the company. It further validates Tryp’s approach to drug development and also serves as a considerable derisking catalyst moving forward,” CEO, Jason Carroll, said.
“Work will now focus on finalising results from the Phase 1b study. This will allow the company to gain a broader understanding of the benefits TRP-8803 may provide to patients, refine and optimise the pharmacokinetic profile for the infusion of psilocin to achieve more precise blood levels and take steps to move TPR-8803 into a Phase 2 patient study for its first specific indication.”