Psychedelics Biotech Startup Launches Phase 1 Study On Ayahuasca's Active Ingredient

Psychedelics biotech startup Entheon Biomedical ENBI ENTBF announced the approval by the local Dutch ethics committee for a Phase 1 clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of the psychedelic compound DMT.

DMT is known as the active ingredient in ayahuasca, a ceremonial hallucinogenic concoction traditionally used by indigenous communities in some parts of South America.

"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. 

The company aims to further DMT research into nicotine addiction, smoking cessation and substance abuse disorders as main indications.

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The Trial Details

The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands. Patient screening is scheduled to begin this month.

The trial will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers. This phase 1 study is expected to provide essential safety and dosing data.

“These results will form the basis for Entheon's phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders," says Dr. Andrew Hegle, chief science officer of Entheon. 

"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," he added.

Hegle said it’s crucial to 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.

Photo by Diane Serik on Unsplash