Shipment of GMP DMT, In Vitro HERG and Genotox Assays Completed, and In Vivo Toxicity Assays Underway

 

Vancouver, British Columbia–(November 24, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company”), a biotechnology company focused on developing psychedelic medicines to treat addiction, is pleased to provide an update on its upcoming human trial, EBRX-101 and on nonclinical DMT initiatives.

 

Clinical Trial Update

The Company announces today that GMP DMT drug product has shipped from Ofichem Laboratorium to CHDR’s partner pharmacy. Formulation and stability testing of the DMT drug product by CHDR’s partner pharmacy has commenced in accordance with the projected start date of EBRX-101, a study that will evaluate the pharmacodynamics, pharmacokinetics and safety of a target controlled intravenous infusion of N, N-dimethyltryptamine (“DMT”) in a population of healthy smokers.

Pre-Clinical Update

With the understanding that DMT possesses a favourable safety and toxicology profile based on historical preclinical and clinical research, Entheon has embarked on several pre-clinical studies to further characterize the drug in support of Entheon’s specific clinical pathway and to satisfy anticipated requirements for a future meeting with the FDA. In connection with its nonclinical program, Entheon is pleased to announce that in vitro HERG and genotox assays have been completed, and in vivo toxicity assays have commenced with final reports for both studies expected in the fourth quarter of 2021.

“Entheon’s science team is pleased to report that formulation and testing of the DMT drug product is currently underway in preparation for our upcoming human trial. In parallel, we are making great progress with our preclinical toxicology program, which is expected to bolster the abundant safety data available in the published DMT literature,” said Andrew Hegle, PhD, Chief Science Officer of Entheon.

 

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. 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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Entheon Biomedical Provides Update on Clinical and Preclinical DMT Programs