Tryptamine Therapeutics has announced the completion of subject dosing in its Phase Ib clinical trial of TRP-8803, an intravenous (IV)-infused formulation of psilocin, targeting obesity. The trial, conducted at CMAX Clinical Research in Adelaide, Australia, compared pharmacokinetic parameters in obese patients with data from previous non-obese studies. This milestone sets the stage for optimizing the dose in upcoming Phase II clinical programs.
The Phase Ib trial, which commenced on November 21, involved three participants who each received the TRP-8803 therapy for 140 minutes. According to the company, all participants tolerated the treatment well and were safely discharged post-study. The data from this phase is expected to be released before the end of the year.
TRP-8803: Overcoming Limitations of Oral Psilocybin
TRP-8803 is Tryptamine Therapeutics' lead candidate, designed to overcome the limitations associated with oral psilocybin. The IV formulation allows for a faster onset of action (under 20 minutes) and precise control over the depth and duration of the psychedelic state. This is a significant advantage compared to the one-to-two-hour onset typically observed with oral psilocybin.
Jason Carroll, CEO of Tryptamine Therapeutics, stated, "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."
Prior Clinical Successes and Future Plans
Tryptamine Therapeutics has previously reported positive results with psilocybin-based therapies. A Phase IIa trial of oral psilocybin (TRP-8802) for binge eating disorder at the University of Florida demonstrated an over 80% reduction in binge eating episodes. Additionally, a Phase IIa trial for fibromyalgia was completed in collaboration with the University of Michigan. The company is also conducting a Phase IIa trial with Massachusetts General Hospital to treat abdominal pain in irritable bowel syndrome (IBS) patients, initially using TRP-8802 but with plans to transition to TRP-8803 based on positive outcomes.
Advantages of IV-Infused Psilocin
TRP-8803 offers several potential benefits over oral psilocybin, including faster onset, more precise control of the psychedelic state, and significant reductions in treatment duration. A key advantage is its inherent reversibility, allowing for rapid termination of treatment in case of adverse events, a safety feature not achievable with oral dosing.
"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," Carroll added.
Advancing to Phase II Trials
With the Phase Ib study objectives met, Tryptamine Therapeutics is now planning Phase II trials to explore the efficacy of TRP-8803 in specific therapeutic indications. The company aims to leverage the data from the Phase Ib trial to design extensive Phase II trials and broaden the application of TRP-8803 across its clinical program.
