Tryptamine Therapeutics (Tryp) has announced the completion of subject dosing in a Phase Ib clinical trial of its psilocin-based intravenous (IV)-infused formulation, TRP-8803, focused on treating obesity.
The trial, conducted at CMAX Clinical Research in Adelaide, aimed to compare pharmacokinetic parameters in obese patients with those from previous non-obese studies.
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It commenced on 21 November and treated three participants with the therapy for 140 minutes each.
All the participants were reported to have gone through the treatment well and were safely discharged post-study.
The findings, expected before the year-end, will inform dose optimisation for the upcoming Phase II clinical programme.
TRP-8803, with its neuroplastic benefits, is the company’s lead candidate. Its formulation is designed to overcome the limitations of oral psilocybin.
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By GlobalDataThe company previously completed a Phase IIa trial for binge eating disorder at the University of Florida, showcasing an over 80% reduction in binge eating episodes.
Additionally, a Phase IIa trial for fibromyalgia has been completed in collaboration with the University of Michigan.
Currently, the company is conducting a Phase IIa trial with Massachusetts General Hospital to treat abdominal pain in irritable bowel syndrome patients.
These studies use TRP-8802, an oral psilocybin, with plans to switch to TRP-8803 based on positive outcomes.
Tryptamine Therapeutics CEO Jason Carroll said: “All subjects that underwent treatment did so safely and were all discharged after the administration, marking the achievement of an important early-stage clinical objective and also confirming the potential of TRP-8803 to deliver improved health outcomes in a timely manner.
“We look forward to receiving the final dataset from CMAX, which will assist in our ongoing planning for Phase II trials to explore the efficacy of the application over specific unmet need states with large addressable market opportunities.
“The completion of subject dosing for the Phase Ib study will now allow the Company to expand its proprietary dataset across a broad patient population in a timely and cost-effective manner, as we continue to diligently execute on our comprehensive clinical development pathway for TRP-8803.”
