A pressing need for new treatment options for people suffering from mental health issues has opened the door to a new era of mental health innovation. Researchers, regulators, and consumers are increasingly wary of the side effects and potential for abuse associated with established pharmaceutical mental health treatments such as Pfizer Inc’s (NYSE:PFE) Xanax and Eli Lilly and Company’s (NYSE:LLY) prozac, and these concens have spurred a wave of research into alternative treatments for common mental health concerns like anxiety, depression, and post-traumatic stress disorder. Now, emerging biotech companies such as Mydecine Innovations Group (CSE:MYCO) (OTC:MYCOF), COMPASS Pathways (NASDAQ:CMPS), and even established giants like Johnson & Johnson (NYSE:JNJ) are taking evidence-based approaches to drugs previously overlooked due to stigmatization.
Mydecine Innovations Group Builds Key Research Partnerships
Mydecine Innovations Group (CSE:MYCO) (OTC:MYCOF) is one of the leading companies in research, development, and commercialization of psilocybin-based medicine. Mydecine holds a full Health Canada Schedule 1 Controlled Drugs and Substances Dealer’s Licence, allowing the company to cultivate, transfer, sell, and export pharmaceutical-grade psilocybin mushrooms for controlled therapeutic uses. The company is conducting key psychedelic medicine research out of its state-of-the-art mycology lab in Denver, Colorado, while bringing evidence-based treatments to market. Through its Mindleap subsidiary, Mydecine has also developed and launched the industry’s first psychedelic therapy-focused telehealth platform.
Mydecine has been working with several world-class public and private research organizations for its studies and clinical trials on psychedelic therapies, including the University of Maryland and University of Ottawa Institute of Mental Health Research. Late last year, Mydecine announced that the company had engaged a full-service contract research organization, ethica CRO, for Phase 2A of its clinical trials of psilocybin for post-traumatic stress disorder.
“We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine’s upcoming Phase 2A PTSD clinical trials,” Mydecine CEO Josh Bartch said in the company’s release. “Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine’s clinical development. We believe that with ethica CRO’s deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States.”
On February 24, Mydecine announced an exclusive partnership with Applied Pharmaceutical Innovation (API) at the University of Alberta. The partnership significantly expands Mydecine’s research capacity and could accelerate both of the company’s drug development programs.
“With our expanded relationship with API, we can now synthesise multiple molecules concurrently as well as run research and development and pre-clinicals on site,” said Rob Roscow, Chief Scientific Officer and Co-founder of Mydecine. “We now have the ability to accelerate both natural product research and novel drug design, specifically in the field of serotonin psychedelics. This will serve to boost our patent portfolio and increase our speed to bring these drugs to market.”
Companies Develop Alternative Treatment Options
Companies like Mydecine Innovations Group are working to address a vital need for new mental health treatment options. Dependence is a serious concern for many existing treatments for anxiety and depression, contributing to more than 18 million people misusing prescription drugs in the United States in 2017 alone. As of September last year, the FDA requires benzodiazepines like Pfizer’s (NYSE:PFE) Xanax to come with warning labels outlining the risks of addiction, abuse, dependence, and withdrawal. Risks of serious side effects, including suicidal behavior, are cause for concern as well, causing the FDA to require warnings on drugs like Pfizer’s Zoloft and Eli Lilly and Company’s (NYSE:LLY) Prozac.
COMPASS Pathways (NASDAQ:CMPS) became the first company to receive breakthrough therapy designation from the FDA for a psychedelic treatment in 2018, and last year, the company became the first psychedelics company to list on a major US exchange. On February 9, COMPASS announced that the company had expanded its Discovery Center through collaborations with laboratories at UC San Diego, School of Medicine, and Medical College of Wisconsin, further developing the company’s ability to develop new optimised psychedelic compounds to address unmet medical needs.
Johnson & Johnson’s (NYSE:JNJ) subsidiary Janssen received expanded use authorization from the European Commission in February for its esketamine-derived nasal spray, Spravato, developed for treatment-resistant depression. The drug had already received approval from the FDA in 2019 and has been touted as a much needed alternative to conventional antidepressants.
Previously overlooked treatments for common and serious mental health issues are now being developed into evidence-based solutions thanks to the work of companies like Mydecine Innovations Group.
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