Tryptamine Therapeutics Ltd (ASX:TYP) has achieved a major milestone in assessment of its use of hallucinogen psilocin to treat illnesses and various psychological conditions, with a Safety Committee ruling that the company’s IV-infused psilocin was safe among health volunteer participants dosed in a clinical setting.
Under the trial, 11 participants were dosed with TRP-8803 via IV-infusion at varying levels for up to 150 minutes.
The decision marked the end of the Phase 1b Healthy Human Volunteer study for the IV-infusion, TRP-8803, with the company now moving into a through assessment of the trial data, in preparation for a broader Phase 2 trial.
Further development of this therapy will be shaped in part by TYP’s success in Phase 2a trials for an oral psilocybin treatment – TRP-8802 – which revealed strong health outcomes for patients with both Binge Eating Disorder and Fibromyalgia in respective trials.
Chief executive officer Jason Carroll said the next phase of assessment would enable TYP to check the qualities and benefits of the treatment to patients.
“The safety clearance provided by the SRC on TRP-8803 is a majormilestone for the company,” he said.
“It further validates Tryp’s approach to drug development and also serves as a considerablederisking catalyst moving forward.
“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.”
TYP has been trading at 2 cents.
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