Vancouver, British Columbia–(Newsfile Corp. – February 3, 2022) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, announced today the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT). The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.
The EBRX-101 study is the core research focus of Entheon Rx™, one of the Company’s business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues. The study 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 will provide Entheon with essential safety and dosing data, providing the foundation for further research of DMT’s therapeutic potential.
“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,” says Dr. Andrew Hegle, Chief Science Officer of Entheon. “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.”
DMT is a classic hallucinogen, similar to LSD or psilocybin in that it exerts many of its subjective, visual, and potentially therapeutic effects via the brain’s serotonin system. DMT differs from the other serotonergic psychedelics in that it is naturally found in the body in trace amounts, and when given externally is rapidly metabolized, with subjective effects returning to baseline after roughly thirty minutes post- administration.
“Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work,” says Timothy Ko, CEO of Entheon. “In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive studies of DMT to date. This clinical trial will serve as a benchmark for further investigation into the development of DMT as a treatment for addiction disorders.”
About Entheon Biomedical Corp.
Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N, N-dimethyltryptamine (DMT) as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.
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Cautionary Note on Forward-Looking Information
This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the timing and the commencement of EBRX-101 site initiation; the timing and initial screening, successful patient recruitment and enrollment; whether the results of the study will provide adequate data; whether the results of the phase 1 trial will be sufficient for a phase 2 trial and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company, including, but not limited to, assumptions relating to the continued impact and status of COVID on the Company’s personnel and planned research activities, that general economic and political conditions will remain the same, stability in applicable law and regulations and that future studies will occur. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.
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