As pioneers of a leading-edge addiction recovery solution based on psychedelic medicine, Entheon Biomedical Corp. (CSE: ENBI) (FSE: 1XU1) has been actively expanding its business over the past weeks. The culmination of that work is the release of a potentially groundbreaking product in the field of psychedelic therapy, which would also represent the company’s first revenue stream.
Proprietary Genetic Test Kit
This week, Entheon announced the launch of the industry’s first psychedelics genetic test kit. The product is developed by its wholly owned subsidiary HaluGen Life Sciences Inc. and is now available for sale within Canada.
The genetic test kit is designed to identify specific DNA biomarkers in order to gauge the risk and potential of adverse reactions toward hallucinogenic drugs such as the DMT-based products championed by Entheon.
HaluGen’s psychedelic pre-screening platform and DNA testing tools provide genetic, personal, and familial insights to better inform one’s psychedelic-assisted therapy experience. By obtaining DNA test results, both individuals and healthcare professionals are equipped with data to improve patient care and reduce side effects and risk.
The genetic-based testing platform was developed in partnership with Lobo Genetics Inc., a Toronto-based healthcare technology company that has successfully commercialized a THC and CBD genetic test.
Based on a product supply and testing services agreement between Lobo and HaluGen, Lobo has completed the requirements for the commercialization of the psychedelic pre-screening genetic test. These include: the completion of the assay development and technology platform; the creation of operating procedures; and the deployment and successful testing of the technology platform.
The psychedelics genetic test leverages the Polymerase Chain Reaction (PCR) technology, which is a well-established method for genotyping and analyzing DNA. The DNA testing process only requires a few simple steps, making it convenient for customers.
Customers receive a swab kit that is shipped directly to their home, which they can then register on HaluGen’s secure online portal. After a non-invasive cheek swab sample is taken, the kit is returned to be processed at HaluGen’s own testing facility in Toronto. A personalized genetic profile with five individualized sensitivity and risk reports is sent directly to the customer, and they are also given access to pre-screening mental health surveys and relevant peer-reviewed scientific studies.
Customer data is securely protected. HaluGen will only examine a few relevant genetic markers and then destroy the DNA sample as part of the testing process.
Revolutionizing Psychedelic Therapy
According to the company, genetics can play an important role in how an individual responds to psychedelic-assisted psychotherapy.
For example, the HTR2A gene mutation, carried by ~20% of the population, can impact how a person responds to serotonin, which is the primary mechanism of action for serotonergic psychedelics such as psilocybin, LSD and DMT. Another gene, CYP2B6, can influence the metabolism of ketamine for the 10-20% of people that carry a specific CYP2B6 gene variant.
HaluGen’s test kit — the first of its kind in the industry — combines genetic biomarkers and personalized data points (mental health, family history and lifestyle risk factors) to create personalized reports. These are delivered directly to the user’s smartphone, providing a convenient and safe means to better understand an individual’s sensitivity to classical psychedelics and ketamine.
The test also offers insights into the short and long-term potential of psychedelic-induced risks such as psychosis.
“The launch of HaluGen’s psychedelics genetic test is not only a first in the psychedelics industry, but also an important milestone for both Entheon and HaluGen. For patients considering psychedelic-assisted psychotherapy, and providers alike, this product gives greater insight into how an individual’s genetic profile could impact treatment, ultimately improving outcomes,” Entheon’s chief executive officer, Timothy Ko stated in the April 6 news release.
“For Entheon, the launch of this product also represents our first revenue stream as we work to develop commercial partnerships for the mass sale of the test,” Ko added.
The proprietary test kit and platform are also expected to be available for purchase in the US within the coming months. The company is currently pursuing various strategic partnerships with the goal of building brand awareness.
Ethics Approval for DMT Study
While working towards the commercialization of the psychedelic genetic test kit, Entheon has also been making progress in its preparation for early-stage human clinical trials to test the therapeutic benefits of N, N-Dimethyltryptamine (DMT), the hallucinogenic drug central to its addiction treatment solution.
In February, the company announced it had received ethics approval for an upcoming pre-clinical study, to be conducted by Science in Action, an Israeli-based lab specializing in pre-clinical in vivo and in vitro R&D services.
Science in Action has also confirmed that it has received ethics approval for an in vivo non-GLP toxicology study of DMT. Both Entheon and Science in Action have applied for requisite permits to export, receive and research DMT drug products.
The objective of this study is to determine the acute toxicity of IV doses of DMT in a 14-day in vivo study. The study is being performed in advance of the company’s human studies to evaluate DMT’s pharmaco-therapeutic profile for the treatment of substance-use disorders, anticipated to be conducted in Q4 of 2021.
“We are very excited to begin working with the acclaimed team at Science in Action in order to further characterize the toxicology profile of DMT in preparation for upcoming human trials,” chief executive officer Timothy Ko said.
“With the successful submission of our study synopsis and ethics approval obtained, we are one step closer to initiating pre-clinical work in order to further advance DMT’s profile as a therapeutic candidate to treat substance-use disorder.”
New Special Advisor
A week following the DTM study approval, Entheon announced the addition of senior pharmaceutical and technology executive Nancy Maher to the company’s advisory board.
As special advisor of data science and regulatory affairs, Maher will provide expertise on the development of Entheon’s data strategy design, study design, and advise on regulatory relationships and data strategy.
Specifically, she will be consulting on the development and implementation of the company’s data management systems for the collection, organization and analysis of data from upcoming pre-clinical and clinical trials, partnership initiatives, private clinic partnerships, and various technological initiatives.
A 20-year veteran in the pharmaceutical and information technology industries, Maher has significant experience in utilizing and enabling technology to deliver efficiency, productivity, quality and solutions for patients and the public health sector. She has served as an executive and consultant for several major companies including IBM, Gilead, Schering-Plough, Merck, Allergan and Teva Pharmaceuticals.
Maher is currently SVP, Chief Information Officer, North America of Kyowa Kirin International plc, where she is establishing the company’s global digital and technology strategy.
For decades, corporations and governments have both struggled to solve the deepening opioid crisis here in North America.
Entheon Biomedical Corp. (CSE: ENBI) (FSE: 1XU1) is on its way to developing what would be a safe and effective solution for treating addiction and substance-use disorders, potentially changing the way society would approach the drug addiction problem.
Over the past weeks, the company has made several corporate announcements ahead of its upcoming clinical trials involving DMT, the progress of which would be closely watched by investors and the scientific community.
With the commercialization of the industry’s first psychedelics genetic test kit, Entheon has embarked on a growth path that would see the company create more value out of data and technology to serve its customers in the long run.
Entheon Biomedical Corp.
CSE:ENBI, OTC:ENTBF, FSE:1XU1
Shares Outstanding 52.5m
Market cap Cdn$53.5m
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