Entheon Biomedical provides update on clinical and preclinical DMT programs

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Shipment of GMP DMT, in vitro HERG and Genotox testing completed and in vivo toxicity testing in progress

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

Update of clinical trials

The company announces today that the drug GMP DMT has been shipped from the Ofichem laboratory to the partner pharmacy of the CHDR. Formulation and stability testing of the DMT drug product by CHDR’s partner pharmacy has started according to the expected start date of EBRX-101, a study that will assess the pharmacodynamics, pharmacokinetics and safety of intravenous infusion. targeted N, N-dimethyltryptamine (“DMT”) in a population of healthy smokers.

Preclinical update

Knowing that DMT has a favorable safety and toxicology profile based on historical preclinical and clinical research, Entheon embarked on several preclinical studies to further characterize the drug in support of Entheon’s specific clinical pathway and to meet the requirements for a future meeting with the FDA. As part of its non-clinical program, Entheon is pleased to announce that in vitro The HERG and genotox analyzes are completed, and in vivo Toxicity testing has started with final reports for the two studies due in the fourth quarter of 2021.

“The Entheon science team is pleased to announce that the formulation and testing of the drug product DMT is currently underway for our next human trial. At the same time, we are making great progress with our preclinical toxicology program, which should strengthen the abundant safety data available in the published literature on DMT, ”said Andrew Hegle, PhD, Scientific Director of Entheon.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company engaged in the development and commercialization of a portfolio of safe and effective psychedelic therapeutics based on N, N-dimethyltryptamine (“DMT products“) for the purpose of treating substance abuse disorders. Subject to obtaining all required regulatory approvals and approvals, Entheon intends to generate revenue through the sale of its DMT products to physicians , clinics and licensed psychiatrists in the United States, some countries of the European Union and across Canada.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
eglassen@blueskycommunications.com

Caution regarding forward-looking information

This press 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 specifically and without limitation, this press release contains forward-looking statements and information relating to the timing of the commencement of the Company’s planned clinical trial, the completion of in vivo studies, the receipt of reports final in vivo and in vitro studies, to other clinical studies and the expected timeline for results and other matters. Forward-looking statements and information are based on certain key expectations and assumptions made by the management of the Company, including, but not limited to, assumptions regarding the continued impact and status of COVID-19 on staff at the Company and planned research activities, that general economic and political conditions will remain the same, that the Company will receive final reports on time, that preclinical studies will be completed on time, stability of applicable laws and regulations. Although the management of the Company believes that the expectations and assumptions on which these forward-looking statements and information are based are reasonable, one should not place undue reliance on forward-looking statements and information, as no assurance can be given that they are correct. ‘will turn out to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of the Company’s management for the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Because forward-looking statements and information deal with future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently expected due to a number of factors and risks. These include, but are not limited to, an increase in the number of COVID-19 cases worldwide, a negative impact of COVID-19 on the research activities of the Company and its research partners, delays in the schedule of clinical trials expected by the Company as a result of other unknown uncertainties and adverse changes in applicable laws and regulations. Therefore, readers should not place undue reliance on the forward-looking statements and information contained in this press release. Readers are cautioned that the above list of factors is not exhaustive. The forward-looking statements and information contained in this press release are made as of the date hereof and no commitment is made to publicly update or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless required by applicable securities laws. The forward-looking statements or information contained in this press release are expressly qualified by this cautionary statement.

Neither CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/104945


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