June 17, 2021
Psychedelic drugs provide people with more than just “mystical experiences” — there are also potential therapeutic benefits.
The first observation of these psychiatric properties dates back to the 1940s. More promising studies and trials followed even after the prohibition of psychedelic drugs. Long before that, psychedelics were used in traditional medicine and religious practices throughout the Americas to promote mental and physical healing.
Since the turn of the century, there has been a resurgence in psychedelic drug therapy. In recent years, research and personal anecdotes have shown that these substances can conjure up life-changing experiences and induce positive changes for those dealing with a range of mental disorders including substance abuse, post-traumatic stress disorder (PTSD) and depression — just to name a few.
Psychedelics may in fact be a solution, not a problem, to drug addiction. This claim is backed by science and factual experience.
Now, many within the science community and on Wall Street are starting to take notice. In September 2020, psychedelics gained further traction with the initial public offering of UK-based Compass Pathways (NASDAQ: CMPS), the first psychedelics firm to list on a major US stock exchange. Its shares skyrocketed following the IPO, trading at nearly twice the offering price.
One rising drug developer that looks to follow that “pathway” is Entheon Biomedical Corp. (CSE:ENBI), which went public on November 12, 2020. The company believes psychedelics have the potential to offer a powerful solution for the addiction epidemic that is scourging North America and the world.
The opioid crisis
Opioid medications, used to relieve pain by driving up the brain’s dopamine levels, are exceedingly addictive.
Beginning in the late 1990s, the volume of opioid prescriptions in the US began to spike, resulting in a proliferation of drug overdoses and suicide cases for the years that followed.
Deaths linked to prescription and illegal drugs increased nearly sixfold between 1999 and 2018, with over 750,000 people having died from a drug overdose.
North of the border, Canada has experienced a similar crisis, with 19,355 opioid-related deaths between January 2016 and September 2020.
So far, the available treatments for drug abuse have proven to be too costly, ineffective, or both. The cost of attending a drug treatment center can reach thousands of dollars a day, with success rates as low as 5% and high probability of repeat visits.
The International Narcotics Control Board estimates that, from a global perspective, only one in six patients, some 4.5 million people worldwide, receive adequate treatment.
The healthcare system in the US is not conducive to treatment efforts either. According to a US Surgeon General report, substance use disorder treatment “remains largely segregated from the rest of healthcare and serves only a fraction of those in need.”
Closing the treatment gap
This imbalance between demand and supply in the substance abuse treatment market can only mean one thing: opportunities for addiction-treatment providers. This market is forecast to expand at a CAGR of 8.7%, reaching a value of US$27.9 billion by 2025.
One of the first companies to recognize this severe lack of treatment options was Entheon Biomedical (CSE:ENBI) which is researching and developing its own psychedelic products to close the “treatment gap.”
For hundreds of years, consciousness-altering psychedelic compounds have been used by indigenous groups (in the form of ayahuasca, psychoactive mushrooms, etc.) to promote psychological and physical healing, and have been studied for a half-century by the Western medical and scientific community.
“Entheon Biomedical believes that people suffering from life-inhibiting addiction disorders, should have access to all scientifically-validated treatment protocols,” says CEO Tim Ko.
Ko believes that psychedelic therapies are the way forward for treating addictive disorders because they have been shown to address the underlying cause of addictions, not just symptoms.
For now, Entheon Biomedical is solely focused on DMT, the most powerful classic psychedelic. Unlike other psychedelics such as LSD and psilocybin, DMT has the unique quality of being very short acting. From the standpoint of costs and scalability, the immediate and powerful nature of the molecule make it the ideal candidate for medical use.
Entheon’s DMT program
A naturally occurring psychoactive compound, DMT is derived from a number of plant species and can be synthetically produced in laboratories.
Much of the early discovery work was pioneered by Rick Strassman, a clinical associate professor of psychiatry at the University of New Mexico School of Medicine, in the 1990s.
Over the course of five years, Strassman built a profile for DMT by administering hundreds of doses of intravenous DMT to 60 volunteers.
Following the study, DMT was dubbed the “spirit molecule” because of its many effects, including inciting powerful emotions, feelings of overwhelming significance and mystical experiences.
These are qualities integral to overcoming addiction.
Currently, Ko’s company is developing a modified dosage form of DMT that will be administered to the patient by continuous intravenous infusion. This dose form will make the experience gradual, safe, and precisely bring the patient to a therapeutic level of immersion.
It differs from other psychedelic experiences, in that if a patient has an adverse reaction, the experience can be stopped safely and quickly without the need for sedatives or other drug interventions. The patient can also request modification or cessation of treatment at any time.
Understanding that the root cause of a substance-use disorder is psychological in nature, the company will combine its DMT protocol with various types of psychological support therapies, such as cognitive behavioural therapy and motivational enhancement therapy.
Human clinical trial set for Q4
To assess the safety and tolerability of DMT in humans, management has prepared clinical trials with Clinical Research Organization (CRO) partner CHDR, to better characterize DMT’s central nervous system effects and its impacts on subjective experience. The study, designed to provide understanding and scientific validation for DMT’s potential as a therapy for substance-use disorders, specifically nicotine addiction and opioid use disorder, is set to begin in Q4 of this year.
In February, the company 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 research. The study’s objective is to determine the acute toxicity of intravenous doses of DMT in a 14-day “in vivo” study. (in vivo refers to research done within a living organism; in vitro describes work performed outside of an organism)
First psychedelics genetic test kit
In April, Entheon announced the launch of the industry’s first psychedelics genetic test kit. The product was developed by its 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 gene-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.
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 testing facility in Toronto. A personalized genetic profile with five individualized sensitivity and risk reports is sent to the customer, who is 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.
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 for 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.
Lobo Genetics acquisition
As a follow-up to the test kit announcement, this week Entheon said it will acquire Lobo Genetics through a wholly-owned subsidiary.
The all-shares transaction stipulates that Entheon will issue 5 million of its shares to Lobo, in a series of four issuances to take place within one year of the closing date. The company will also issue 9,603 stock options to Lobo stock option holders, and up to 46,944 warrants, to Lobo warrant holders.
In addition to the psychedelic genetic test that Lobo has developed in partnership with HaluGen Life Sciences, Lobo is also offering a cannabis genetic test. The test is capable of
providing personalized insights into an individual’s cannabis metabolism, risk and impairment, including: the ability to metabolize THC and CBD; increased acute psychotomimetic effects and long-term risk of cannabis-induced psychosis; and neurocognitive impairment including short-term memory loss.
“This acquisition supports Entheon’s genetic-driven approach to developing personalized psychedelic-assisted psychotherapeutic (PAP) protocols to treat substance use disorders while providing in-house DNA data analytics, expanded assay development and genetic research capacities,” Entheon’s CEO, Tim Ko, said in the June 16 news release. He added:
“With the acquisition of Lobo comes the addition of key staff members and enhanced expertise in the field of genetics. With increased capacity to screen patients, on a genetic basis, for underlying psychiatric disorders prior to undertaking PAP, Entheon is furthering its commitment toward safety and predictability in psychedelic therapies while aggregating data that can be used to determine which psychedelic molecules are best-suited for a particular patient.”
Entheon Biomedical appears to be well on its way to developing a safe and effective solution for treating addiction and substance-use disorders, potentially changing the way society approaches drug addiction.
In April the company launched the industry’s first psychedelics genetic test kit, setting it on a path to creating more value out of data and technology to serve its customers.
This month, by acquiring Lobo Genetics, Entheon adds cannabis genetic testing to its screening platform technology and data, thus strengthening its psychedelic-assisted protocols.
We should also mention that in May, Entheon entered into a drug supply agreement with Ofichem, a Dutch company. Ofichem will provide Entheon with DMT, as well as the required analytical data package, for use in the previously announced phase 1 human clinical trial, to be conducted in the Netherlands in Q4.
“This supply agreement with Ofichem will enable the delivery of GMP-grade DMT for use in our upcoming human clinical trials and is a critical element to the success of the study,” said CEO Tim Ko. “Ofichem’s significant experience in organic synthesis, analytical chemistry and drug development make them an ideal European partner for this initiative. We look forward to updating shareholders further as we advance through the preparation steps leading to the commencement of the clinical trial.”
Entheon Biomedical Corp.
CSE:ENBI, OTC:ENTBF, FSE:1XU1
Shares Outstanding 54.0m
Market cap Cdn$22.6m
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