Entropy Neurodynamics Limited, an Australian clinical-stage biotechnology company, is set to initiate a US Phase 2 clinical trial of its precision-controlled psychedelic therapy, TRP-8803. This trial, in collaboration with the University of California, San Francisco, will compare the efficacy of TRP-8803, an IV-infused psilocin, to escitalopram, a leading antidepressant, in young adults with Major Depressive Disorder. Aiming to improve upon the limitations of oral psilocybin, TRP-8803 is designed to provide rapid onset and precise control over the psychedelic experience. The trial will be conducted under the leadership of Professor Robin Carhart-Harris, a preeminent researcher in the field, and is a key component of Entropy's strategy to establish a robust clinical and regulatory framework in the US. The trial is expected to commence in the first half of 2027, contingent on FDA approval, and will be funded by the company's existing resources and financial incentives.
Key Points
Entropy Neurodynamics Limited is advancing its proprietary TRP-8803 to a US Phase 2 clinical trial.
The trial will compare IV-infused psilocin with the antidepressant escitalopram in young adults with Major Depressive Disorder (MDD).
Entropy has signed a pre-Clinical Trial Agreement with the University of California, San Francisco (UCSF).
The trial aims to assess whether TRP-8803 can serve as an alternative to ongoing daily antidepressant therapy.
This trial is part of a broader clinical and regulatory strategy in the US.
TRP-8803 is designed to address limitations of oral psilocybin by delivering psilocin through IV-infusion.
The trial will be led by Professor Robin Carhart-Harris, a leading researcher in psychedelic therapies.
The study intends to start in the first half of calendar year 2027, subject to FDA clearance.
Entropy aims to use the trial to establish a broader US regulatory pathway and support additional clinical development.
Funding for the trial is secured from existing cash reserves, option conversions, and pending R&D Tax Incentives.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.