
Targeting spring 2023 for a NASDAQ listing.
Targeting spring 2023 for a NASDAQ listing.
Human beings seek treatment for any addiction to any substance (or any behavioral act) that is affecting their social development and their ability to lead a productive life.
While these issues have been part of mental health treatment for decades, there is still much work to be done.
Enter the psychedelics industry, which is discovering new ways to tackle tobacco addiction with psilocybin (with tobacco cessation studies piling up new data), drug addiction (findings that psychedelics can replace opioid use), and other behavioral addictions.
Alcohol addiction has been added to the list of psychedelics therapy through the focused work of Awakn Life Sciences (OTC: AWKNF) a Vancouver-based biotechnology company founded in June 2020, that is researching, developing, and delivering psychedelic therapeutics to treat addiction, including the treatment of alcohol use disorder (AUD).
Awakn was reportedly created when founders bought a controlling stake in Dr. Ben Sessa’s private practice, Mandela Therapy Limited. Sessa is now the co-founder and chief medical officer of Awakn.
AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Considered a brain disorder, AUD can be mild, moderate, or severe. Lasting changes in the brain caused by alcohol misuse perpetuate AUD and make individuals vulnerable to relapse, adding to the treatment difficulty.
In mid-March, Awakn Clinics in London got Care Quality Commission’s (CQC) formal approval to begin treatments for addiction and mental health. This flagship clinic is Awakn’s third clinic, adding to the company’s two operating clinics located in Bristol, England, and Oslo, Norway.
The clinics use ketamine-assisted therapy to treat addiction and several mental health disorders, including AUD, using a treatment protocol developed in their recently published Phase II a/b clinical trial.
This study demonstrated that treatment with three infusions of ketamine was well tolerated in patients with AUD and was associated with more days of abstinence from alcohol at the 6-month follow-up.
In February, Awakn filed a patent application for a new chemical series of entactogen-like molecules. Entactogen-like molecules are a class of psychoactive substances that produce distinctive emotional and social effects that Awakn believes have the potential to treat both substance and behavioral addictions, according to a press release.
These molecules have the potential to treat addiction by delivering improved efficacy in a shorter treatment time.
As a result of that discovery about Entactogen-like molecules, it’s not just alcohol addiction that Awakn is working on. In January, the company decided to expand its existing ketamine study to include three other behavioral addictions, including binge eating disorder, compulsive sexual behavior, and internet gaming disorder. To back up the need for expanding in these new directions, Awakn cites facts that binge eating disorder affects up to 110 million people globally; internet gaming disorder affects 238 million, and sexually compulsive behavior affects up to 350 million.
The expanded study is to be led by Celia Morgan, Awakn’s head of ketamine-assisted therapy for addiction, and a professor of psychopharmacology at the University of Exeter, U.K. Morgan will investigate a new treatment approach for these behavioral addictions, exploring and monitoring whether ketamine can increase neuroplasticity using electroencephalogram (EEG).
With ground-breaking work like this in its future, Awakn is seen as one of the top psychedelics companies in the industry.
But like many psychedelics companies, Awakn is still in the clinical trial stage of psychedelics development. It trades on both the NEO and the OTCQB and is generally trending down these days, as are a lot of psychedelics. Awakn recorded its first revenue hit of $31,737 in late 2021. But there is still a lot going on with the company.
On the plus side, Awakn’s recent acquisition of the exclusive rights to MDMA research from Imperial College London to investigate the role of MDMA-assisted psychotherapy in treating patients with AUD is seen as a giant step forward in treating alcoholism.
And finally, Awakn has arguably one of the strongest science and research teams in the business, including Chief Research Officer David Nutt, psychiatrist and the Edmund J. Safra Professor of Neuropsychopharmacology in the Division of Brain Science, Dept of Medicine, Imperial College London; and Chief Scientific Officer Shaun McNulty, who has over 25 years of industry experience in the neuroscience drug discovery units of a major pharmaceutical company, including Parke-Davis, Pfizer, and GSK. It’s that sort of firepower that keeps investors on the alert about Awakn’s future.
Novamind Inc. (CSE: NM)(OTCQB: NVMDF) has opened a new clinic located in downtown Salt Lake City to address addiction. The SLC Clinic specializes in integrative behavioral health and services for adults with substance use disorders led by incoming Medical Director, Dr. Amy de la Garza.
Dr. Reid Robison, Novamind‘s Chief Medical Officer, commented: “Social isolation and despair related to the COVID-19 pandemic have further fueled a significant increase in substance use disorders and related deaths. Dr. de la Garza’s expertise in addiction medicine and behavioral health is a vital addition to our team as we continue to expand Novamind’s clinic footprint to address unmet need and broaden our innovative, evidence-based treatments.”
Dr. de la Garza is a board-certified family practice physician with 10 years of experience providing specialized care for patients with behavioral health and SUD diagnoses. She completed an Addiction Medicine Fellowship at the University of Utah and is an Institute for Functional Medicine Certified Practitioner. In 2017, Dr. de la Garza opened the first community-based, co-located primary care and behavioral health practice in Salt Lake City, Utah. “I am thrilled to join Novamind and look forward to establishing an innovative outpatient substance use disorder program that brings together addiction and integrative medicine and treats the whole person,” said Dr. de la Garza, who is also trained in integrative modalities and lifestyle medicine, including nutrition, movement, sleep, stress management, and social connection.
Novamind said that the SLC Clinic’s outpatient SUD services provide an alternative to residential treatment programs and work to address the highly complex public health crisis that is worsening alongside challenges related to access. In 2020 alone, 93,000 Americans died of a drug overdose-an increase of 30% from the previous year, according to the Centers for Disease Control and Prevention.
Novamind said it will collect clinical data on the efficacy of the integrative treatment approach for SUD and host upcoming studies for conditions like opioid use disorder. Additionally, the company said that the SLC Clinic will pilot an innovative and cost-effective group medical visit model that has been shown to reduce anxiety and depression, as well as improve outcomes in chronic conditions like cardiovascular disease and diabetes.
Recent Earnings
In November, Novamind reported that it had total revenue of $1,857,750, an increase of 113% when compared to the same period last year. The company has a debt-free balance sheet with $5,969,673 in cash and $2,018,971 in marketable securities and total working capital of $6,834,011 to fund operations.
“Q1 was a strong start to fiscal year 2022, driven by the addition of another clinic to our network and increased patient demand for our comprehensive range of innovative mental health treatments,” said Yaron Conforti, Novamind’s CEO and Director. “We continue to make progress on our national clinic expansion, most recently with a letter of intent to acquire two locations in Arizona. Our clinical research business has been actively building an exciting pipeline of contracts with leading drug developers.”
Clinical-stage pharmaceutical company Zynerba Pharmaceuticals (ZYNE) announced that researchers at The Scripps Research Institute and the University of Maryland have generated preclinical data from a study funded by NIH grants that suggest potential value in using its transdermal cannabidiol (CBD) (ZYN002) to reduce the risk of relapse among recovering drug and alcohol addicts.
The study results were published a paper entitled, ‘Unique Treatment Potential of Cannabidiol for the Prevention of Relapse to Drug Use: Preclinical Proof of Principle’ (Gonzalez-Cuevas, G et al.) in Neuropsychopharmacology.
“Remaining drug-free is a constant battle for former substance abusers, and their susceptibility to stress and anxiety can increase their vulnerability for relapse,” said Dr. Friedbert Weiss, the investigator for this study and Professor, Department of Neuroscience at The Scripps Research Institute in La Jolla, California. “These preclinical data are interesting as they show that we may be able to use transdermally-delivered CBD to impact multiple dimensions of relapse, namely benefit across a number of vulnerability states and effects that are maintained beyond the brief treatment period. CBD is broadly active and these data provide continued evidence that transdermal CBD may have therapeutic potential in a number of neurological disorders and conditions, including prevention of relapse.”
Weiss and his research associate Gustavo Gonzalez-Cuevas tested the CBD gel on rats that had demonstrated their addiction to alcohol or cocaine. They applied the compound once a day for a week to the rat’s skin. The researchers reported that CBD effectively reduced the tendency to relapse back to alcohol or cocaine when provoked by stress and drug cues. The study also found that the CBD reduced anxiety and impulsivity in the drug-experienced rats. In addition to the immediate results, researchers found that five months after the initial therapy ended, the rates still showed that their relapse tendencies were still reduced.
“The efficacy of the cannabinoid [CBD] to reduce reinstatement in rats with both alcohol and cocaine — and, as previously reported, heroin — histories predicts therapeutic potential for addiction treatment across several classes of abused drugs,” says Weiss. “The results provide proof of principle supporting the potential of CBD in relapse prevention along two dimensions: beneficial actions across several vulnerability states, and long-lasting effects with only brief treatment.” He goes on to say that “Drug addicts enter relapse vulnerability states for multiple reasons. Therefore, effects such as these observed with CBD that concurrently ameliorate several of these are likely to be more effective in preventing relapse than treatments targeting only a single state.”
While the news is encouraging for Zynerba, investors seem to want to see real results for a formal clinical study. The authors of the study believe that insight into the ways that CBD manifests these effects in future studies could create new opportunities for using various CBD compounds to prevent addicts from relapsing and keep them clean. A positive for the entire category.
Zynerba stock was lately trading at $8.85, down from its 52-week high of $25.95 following a slew of less than stellar study results. Eight analysts cover the stock with an average price target of $17.69 according to Yahoo Finance. Several raised their ratings following the stock price plunge.
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