Entheon Biomedical Reports Launching Multiple Studies to Advance Psychedelic-Based Mental Health Treatments

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The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

A growing body of research indicates that psychedelics are safe and potentially effective as treatments for a wide range of psychiatric disorders. Between 2019 and 2020, investments ballooned from about $60 million to over $600 million. 

In 2021, total investments blew past that $600 million in the first 3 months and are expected to exceed $2 billion by the end of the year. It’s been a momentous year for the industry all over the globe. Atai Life Sciences ATAI, a Berlin-based startup researching psilocybin as a treatment for depression and anxiety went public in June. Johns Hopkins received the first federal grant for psychedelic research in 50 years this October. 

Entheon Biomedical ENTBF — a Canadian-based biomedical company researching and developing personalized, patient-centric psychedelic treatments for addiction and substance use disorders — reports that it is progressing its clinical research focused on advancing the therapeutic potential of DMT and identifying predictive biomarkers and other indicators that can help healthcare providers create personalized treatment plans as well as objectively measure patient response during treatment. Here’s a look at the research Entheon began this year and what is planned for 2022.

The Search for Predictive Biomarkers is Underway

At the beginning of November, Entheon announced that recruitment is underway for EBIQ-101, an Open Label Observational Study designed to measure the effect of ketamine on neurological activity as measured by electroencephalogram (EEG).. 

The data collected will be used to inform the understanding of brain activity changes in response to ketamine. In addition, genetic markers across participants will be compared, with data on impact of genetic markers and response to ketamine also being analyzed.

By better understanding a particular person’s response to ketamine treatment, Entheon intends to equip healthcare providers with the capacity to better determine dosing and predict which patients will benefit most from a given treatment. 

"We believe that personalized medicine is the future of psychedelic psychiatry,” Entheon CEO Timothy Ko said in a statement about the research being carried out with Heading Health. “EEG and genetic-based biomarkers will add much-needed layers of data insight which can be used to improve patient care."

Entheon expects to complete the study early next year.

Entheon Set to Begin Human Trials in 2022

EBRX-101 has been designed to be the most rigorous and comprehensive study of DMT to date, and will primarily evaluate the safety, pharmacodynamics and pharmacokinetics of DMT when administered intravenously, with exploratory endpoints that will obtain EEG and genetic data from subjects.  

The Phase 1/2A study is scheduled to start in the first quarter of 2022 at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands, and will be an adaptive single ascending dose, double-blind, randomized, placebo-controlled study with up to 5 cohorts of 10 subjects. 

In support of the upcoming trial, the Scientific Review Committee at CHDR has conducted a review and risk analysis of the clinical study, and has endorsed Entheon's clinical study protocol for submission to the medical ethics committee. In addition, GMP DMT drug product has already shipped to CHDR’s partner pharmacy and is undergoing formulation and stability testing.

This study is an exploratory step for Entheon as they seek to develop DMT treatments for the indications of nicotine addiction, alcohol-use disorder and opioid-use disorder, all of which lack  efficacious treatments. That said, prior to exploring the clinical efficacy of DMT for specific addiction indications, it is crucial to establish the safety profile, as well as the PK/PD relationship between continuous infusions of DMT at increasing doses.

As Entheon continues investing in research and development, it believes that it is moving closer to its ultimate goal of developing a uniquely personalized system of treating patients with psychedelics. The hope is to identify a set of biomarkers that can reliably predict how a patient will respond and a set of objective measures, like EEG data, to measure that response so that treatments can be adapted to the specific needs of each patient.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.