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  • Entheon Biomedical (ENBI) provides corporate update on studies and clinical trials
  • Approval of the observational study was received on October 22, 2021 from the Internal Review Board
  • An agreement has been signed with Wavepaths Ltd., a company that collaborates with artists to develop adaptive music for use during psychedelic therapy
  • DMT drug material from Psygen Labs Inc. has been shipped to Entheon’s Israeli pre-clinical research partners, Science in Action and Pharmaseed Ltd
  • Entheon expects that its Phase 1 human trial will now begin in Q1 of 2022
  • Entheon Biomedical Corp. (ENBI) is up 13.21 per cent and is trading at C$0.30 at 11:47 am ET

Entheon Biomedical (ENBI) is pleased to provide an update on its operations and progress on its strategic initiatives.

Entheon’s observational study assessing the neurophysiological effects of ketamine is progressing as planned. Approval of the observational study was received on October 22, 2021, from the Internal Review Board and site initiation has been completed with patient recruitment to begin shortly.

In partnership with Heading Health, LLC, this clinical trial will use electroencephalography (EEG) and genetic screening to investigate biomarkers associated with ketamine treatment for major depressive disorder. Study results will further advance Entheon’s biomarker program for characterizing various drug states and mental health disorders.

In addition, an agreement has been signed with Wavepaths Ltd., a company that collaborates with world-class artists to develop adaptive music for use during psychedelic therapy. Pursuant to the agreement, Wavepaths will provide Entheon with audio for ketamine therapy sessions conducted at Heading Health as part of the observational study.

The Wavepaths’ audio tracks will be used to control EEG variables related to patient-selected music typically used during treatment. This data set may serve as a baseline which Entheon will build on to explore the impact of music on therapeutic outcomes in subsequent studies.

Entheon confirms that DMT drug material from Psygen Labs Inc. has been shipped to Entheon’s Israeli pre-clinical research partners, Science in Action and Pharmaseed Ltd. This material will be used for both an in vivo acute toxicity study as well as behavioural assays related to alcohol-use disorder. Results of these studies are expected in Q4 of 2021.

The Scientific Review Committee at the Centre for Human Drug Research has conducted a review and risk analysis of the clinical study, with input from the Scientific Advice Board, and has endorsed Entheon’s clinical study protocol for submission to the medical ethics committee.

Entheon expects that its Phase 1 human trial will now begin in Q1 of 2022. Site initiation and initial screening are planned for January, with recruitment and enrollment to follow shortly thereafter.

“We are happy to report that Entheon’s core research programs are progressing steadily with the cooperation of our partners and our shared commitment to advancing Entheon’s biomarker-enabled drug development platform,” said Timothy Ko, Chief Executive Officer of Entheon.

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 for the purposes of treating addiction and substance use disorders.

Entheon Biomedical Corp. (ENBI) is up 13.21 per cent and is trading at C$0.30 at 11:47 am ET.

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