NetworkNewsWire Editorial Coverage: Global destigmatization, changing regulations and an upswing in research are speaking loudly to the opportunity for psychedelics to provide tangible improvements in medicine to address some of the most resistant, devastating and expensive conditions known to man. For decades, drugmakers have spent billions of dollars searching for therapies that can safely help people quit smoking and alleviate anxiety, as well as treat those with notoriously difficult diseases such as autism. Unfortunately, the conventional efforts have been to little avail. Fortunately, meaningful progress is being made with psychedelics across multiple fronts, such as the work of Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (Profile), a biopharmaceutical firm formed in 2020 for the purpose of developing innovative therapeutics to treat PTSD, addiction and other mental health disorders. Mydecine is part of a renaissance for psychedelic medicine research that has captured investors’ attention, albeit through individual companies such as Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) and Seelos Therapeutics Inc. (NASDAQ: SEEL), or through exchange traded funds that provide exposure to a swath of companies, such as AdvisorShares Trust (NYSE ARCA: PSIL) and Horizons Psychedelic Stock Index ETF (NEO: PSYK).
- Cigarette smoking is responsible for 20% of all American deaths every year, creating a $1.4 trillion drain globally in associated costs.
- Mydecine, Johns Hopkins, University of Alabama and NYU are participating in the first clinical research to receive funding from the NIH in more than 50 years.
- MYCOF will be supplying its MYCO-001 to the NIH-funded clinical trial as part of a smoking cessation treatment.
- The company expects to conduct two other clinical trials of MYCO-001 for smoking cessation and PTSD in veterans during 2020
An Opportunity Case Study: Cigarette Smoking
Most people understand the deadly risks associated with cigarette smoking and that nicotine is highly addictive, as addictive as heroin by many accounts. The market is flooded with options (gums, herbals, patches, etc.) for those wanting to quit cigarettes, but these have proven mostly ineffective, leaving the nearly 70% of 34.1 million Americans who want to break their addiction with little in the way of safe and effective smoking-cessation options. Data lends color to the addressable market. Smoking is responsible for 20% of all U.S. deaths and associated healthcare costs and lost productivity of $1.4 trillion annually. According to the CDC, about 55% of smokers have tried to quit, but about 7 out of every 100 succeed.
Now, consider a small study by Johns Hopkins University comparing smokers trying to quit using cognitive behavioral therapy (“CBT”) plus varying doses of psilocybin (the active psychedelic ingredient in “magic” mushrooms) to abstinence rates typically observed in smokers using other medications or CBT alone. The results showed 67% of the participants remained nicotine free at a 12-month follow-up, a substantial increase over success rates for other methods (typically 10% to 35%). Johns Hopkins is following-up with larger efficacy study funded in part by the first National Institute of Health (“NIH”) grant in more than 50 years to directly investigate the therapeutic effect of psilocybin for tobacco addiction.
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) is an integral part of this landmark NIH-funded research led by Johns Hopkins in collaboration with University of Alabama at Birmingham and New York University. Mydecine is supplying its lead drug candidate, MYCO-001 (99% pure psilocybin), for use in the three-year, multisite smoking cessation clinical trial. The supply agreement has multiple benefits for Mydecine, cementing their position as a leader in the emerging psychedelic-assisted psychotherapy industry while allowing them to simultaneously advance MYCO-001 clinical development in collaboration with the biggest names in the business.
The new supply agreement builds upon an existing relationship between Colorado-based Mydecine and Johns Hopkins, considered the top university for psychedelic research globally. Among other things, Mydecine was working with Dr. Matthew Johnson, lead in the NIH clinical studies, professor of psychiatry and behavior sciences at Johns Hopkins and a world-renowned expert on psychedelics, on smoking cessation research and potential upcoming clinical work by Mydecine. Elsewhere, Mydecine in August penned a five-year master collaboration research agreement with Johns Hopkins to evaluate new treatments and compounds for a variety of addiction disorders and mental health conditions.
On Tap: Phase 2/3 Clinical Trial of MYCO-001
Mydecine is aligning for three clinical trials of MYCO-001 in 2022, any (or all) of which could serve as a catalyst for the company. The NIH-funded multi-center study with Johns Hopkins, NYU and UofA-Birmingham is one. Another is a company-sponsored seamless phase 2/3 clinical trial also evaluating the administration of MYCO-001 with a structured smoking-cessation treatment program in nicotine-dependent individuals. Dr. Johnson is serving as the PI (principal investigator) in both clinical studies.
A “seamless” clinical trial has become a buzz word in recent years thanks to FDA commissioner Dr. Scott Gottlieb supporting the format in 2017 as a means to accelerate drug development. The concept is an adaptive design combining at least two of the traditional phases of drug development, with modifications made if necessary following interim data readouts. The design can shave substantial time and costs compared to the conventional FDA pathway of separate phases. Mydecine is expecting an investigational new drug (“IND”) meeting with the FDA by the end of the year and to launch the trial in January 2022. The protocol for the trial is expected to involve weekly individual sessions for five weeks before the patient tries to quit smoking with endpoints including smoking abstinence at three, six and twelve months.
The company is hoping to penetrate a global smoking cessation market estimated by ResearchandMarkets.com growing at a 16.9% compound annual growth rate to $63.99 billion by 2026. This type of growth and market opportunity is likely contributing rationale to Roth Capital analyst Elemer Piros initiating coverage on Mydecine with a Buy rating and C$3 price target.
PTSD in the Underappreciated
While smoking cessation is a vital part of the pipeline, Mydecine is committed to exploring the diverse opportunities of psychedelics to offer relief where other drugs have failed or come with unpleasant side effects. An initial target outside of smoking is post-traumatic stress disorder (“PTSD”) in veterans, emergency medical service (“EMS”) and front-line workers, a group that as a whole goes grossly underappreciated for the day-to-day grind of the job.
There are no medications approved by the FDA specifically for PTSD, only those that are used to attempt to soften the symptoms; the medications are often highly addictive or have side effects of their own. Once again, Mydecine is looking to hold an IND meeting with the FDA this quarter for the purpose to initiate a Phase 2a clinical trial in the first quarter of 2022 evaluating a psychedelic regimen for veterans with PTSD, which it intends to host at three U.S. sites, two Canadian sites and one site in the Netherlands.
Providing a Complete Journey of Healing
As those three trials move forward, Mydecine is addressing other aspects of therapy, including a mindful approach to a holistic journey to recover. Frequently, patients undergoing psychedelic therapy refer to the process as an “experience” following adjectives such as “spiritual” or “religious” or even “out of body” where breakthroughs of the mind are achieved to set forth a durable course of healing by addressing the root issue, rather than just dulling symptoms. As part of this journey, Mydecine offers Mindleap Health, an inner wellness application and community that provides tools for self-discovery. The comprehensive platform introduces users to psychedelic integration, dream analysis and deepening awareness with top experts as a part of a whole healing approach.
Elsewhere, Mydecine has three other flagship drug candidates in its portfolio, including MYCO-003, a psilocybin formulation that combines a serotonin agonist with a serotonin-releasing agent. This formulation is meant to overcome obstacles related to a “bad trip” that can sometimes accompany ingesting psilocybin. This experience, which could be exacerbated in highly anxious patients, requires intervention by the attending physician. Mydecine believes it can mitigate without the need for extensive supportive care through its novel formulation. The company has recently reported positive preclinical data on MYCO-003 and filed a patent application as an anxiety-reducing product.
Don’t Call It a Comeback
Believe it or not, there was a growing body of evidence supporting the therapeutic benefits of psychedelics ongoing in the mid-20th century. However, the emphasis on a counter-culture and President Richard Nixon signing into law the Controlled Substance Act in 1970 put the kibosh on psychedelic clinical research. A half century later, the stigma is fading, the data is becoming indisputable and investments are growing to bring new treatments to market.
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) is one of the most recognizable names in the market. The company is assembling a drug-development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. Most recently, MindMed expanded its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses that include Autism Spectrum Disorder (“ASD”).
Seelos Therapeutics Inc. (NASDAQ: SEEL) is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (“CNS”) disorders and other rare diseases. The company’s portfolio includes several late-stage clinical assets targeting indications including acute suicidal ideation and behavior (“ASIB”) in major depressive disorder (“MDD”) or PTSD, amyotrophic lateral sclerosis (“ALS”), Sanfilippo syndrome, Parkinson’s Disease, and other psychiatric and movement disorders plus orphan diseases.
AdvisorShares Trust (NYSE ARCA: PSIL) invests in the emerging psychedelic drugs sector, offering exposure to those biotechnology, pharmaceutical and life sciences companies the managers see as leading the way in this nascent industry. PSIL concentrates its portfolio on companies deriving the majority of their net revenue or devoting the majority of their assets to psychedelic drugs. PSIL is considered an alpha opportunity since it targets early growth in a nascent sector.
Horizons Psychedelic Stock Index ETF (NEO: PSYK) was launched in January 2021, making it the world’s first exchange traded fund focused on the emerging psychedelics opportunity led by life science and pharmaceutical companies. The ETF was created in response to a growing number of public companies in North America adding to the body of clinical research demonstrating the potential use of psychedelic compounds, such as psilocybin and ketamine, as treatment for mental illness, depression, addiction, PTSD, and other medical conditions.
On the back of strong investor appetite and hundreds of millions of dollars in funding, psychedelic research is gaining sustainable momentum and mainstream credibility. The days of viewing psychedelics as merely amusements of counterculture are fading and the very real possibility exists that novel psychedelic therapies are on the horizon to help so many people in need that have been failed by traditional drugs.
For more information about Mydecine Innovations, please visit Mydecine Innovations Group.
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