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, is pleased to provide an update on its patent portfolio as well as nonclinical and clinical programs.
US Provisional Patent Filed
In furtherance of its program, the Company filed US Provisional Patent Application No. 63/283,051, titled "Detection of Therapeutic Psychedelic State," as of November 23, 2021. The patent relates to improved technology for detection and maintenance of the optimal therapeutic psychedelic state, which Entheon intends to study through the monitoring of electroencephalogram (EEG) biomarkers in order to optimize the treatment of neuropsychiatric conditions.
"Entheon is proud to be making significant strides in its Entheon IQ™ program," says Timothy Ko, Chief Executive Officer of Entheon. "With the filing of our provisional patent application, Entheon is building an IP foundation to better facilitate safe and precise use of psychedelics to deliver improved patient outcomes."
In Vivo Toxicity Assays Completed
Further to the Corporate Update provided on November 24, 2021, the Company is pleased to announce further progress on its nonclinical program. In vivo toxicity assays have been completed with our CRO partner, with a final report expected in the coming weeks. Along with the previously completed in vitro assays, these studies serve as the benchmark for further preclinical work in 2022 and will contribute to regulatory submissions as the company advances its DMT program.
EBRX-101 on Track to Submit Regulatory Package for Human DMT Clinical Trial
The Company is pleased to confirm that it is on track to submit its regulatory package to the Dutch ethics committee in early 2022 for its upcoming human trial. 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.
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.
For more information, please contact the Company at:
Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
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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
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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 grant of the patent, if at all; timing and issuance of in vivo toxicity assay reports, the timing and submission of the regulatory package for EBRX-101, the commencement of certain pre-clinical studies and the expected timeline for results 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 that the Company will receive the in vivo toxicity reports timeously, will be able to prepare the regulatory within the time frame expected, and that the Company will submit the EBRX-101 regulatory package within the expected timeframes. 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.
Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, a rise in the number of COVID cases globally, an adverse impact of COVID on the research activities of the Company and its research partners, the inability to prepare the IMPD submission within the time frame expected, difficulties in subject enrollment, initial screening or site initiation, delays to the Company's planned clinical trial timeline as a result of other unknown uncertainties and adverse changes to applicable law and regulations. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.
Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
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March 29, 2022 February 24, 2022 |
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