Entheon (ENBI) has been approved by a local Dutch ethics committee for its DMT clinical trial.
The phase 1 trial, known as EBRX-101, will evaluate the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT).
The company will conduct the study at the Centre for Human Drug Research in Leiden, Netherlands, with patient screening scheduled to begin this month. The study will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT administered to otherwise healthy smokers.
Entheon hopes to compile safety and dosing data to support its phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders.
“Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work,” said Timothy Ko, CEO of Entheon. “In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive study of DMT to date.”
Entheon Biomedical develops and commercializes safe and effective DMT-based psychedelic therapeutic products.
Entheon (ENBI) is down by 2.17 per cent trading at $0.225 per share as of 9:30 am EST.