Biotechnology company focused on research and development of psychedelics medicines to provide personalized treatment for addiction disorders Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) announced having being granted approval by local Dutch ethics committee for the EBRX-101- a phase 1 clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of DMT.
This study is the main research focus of Entheon Rx™ one of the company’s business unit and it will be carried out at the Centre for Human Drug Research, in Leiden, Netherlands. The unit is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues Patient screening for the study is set to kick off this month.
The study will be using an adaptive, double-blind, randomized placebo-controlled design with a single ascending dose of intravenous DMT which will be administered through continuous-controlled infusion to a population of healthy smokers.
Just like LSD and psilocybin, DMT is a classic hallucinogen which exerts many of its subjective, visual, and potentially therapeutic effects through the serotonin system of the brain. However, DMT differs from the other psychedelic compounds in that it is naturally found in the body in trace amounts.
The company’s chief science officer, Dr. Andrew Hegle, says the study will provide the company with essential safety and dosing data laying the foundation for further research of the therapeutic potentials of DMT.
“DMT’s unique metabolic and neuroprotective properties together with its record of safe human use in the scientific literature, suggests that it is an ideal candidate for therapeutic administration. However, it is crucial that we thoroughly investigate the pharmacological properties and safety profile of infused DMT in a clinical setting, and fully characterize its effects on the central nervous system. These results will form the basis for Entheon’s phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders,” said the CSO.