- Studies suggest that psychedelics such as psilocybin and MDMA offer health benefits when used to treat patients with depression and PTSD
- These results have encouraged scientists, psychotherapists, and entrepreneurs, who say that FDA approvals may be on the horizon
- Mydecine is playing a vital role in pushing the knowledge of the benefits of psychedelic compounds by undertaking clinical research in partnership with academics
- In a recent interview, company CEO Josh Bartch emphasized the need for consistent messaging to push the adoption of psychedelics among the medical community, and help assuage concerns of patients who may be wary of psychedelic treatments
Fueled by the extremes of the counterculture witnessed in the ‘60s and ‘70s, psychedelics acquired a soiled reputation that drove stereotypical connotations, which are only wearing off years later thanks to efforts by researchers. Results from one study published in the New England Journal of Medicine, for example, showed the benefits of using psilocybin as a treatment for depression (https://ibn.fm/LfyUe). Another clinical trial published in the Nature Medicine journal established that MDMA (commonly known as Ecstasy and Molly) combined with counseling brought noticeable relief to patients with severe post-traumatic stress disorder (“PTSD”) (https://ibn.fm/rEBcb).
As a result, a 2021 New York Times article observed that the scientific and psychotherapeutic communities had been enthused, further noting that “[scientists, psychotherapists, and entrepreneurs in the field of psychedelic medicine] say it is only a matter of time before the Food and Drug Administration grants approval for psychoactive compounds to be used therapeutically – for MDMA as soon as 2023, followed by psilocybin a year or two later” (https://ibn.fm/HujeN).
These speculations are part of a rising tide of positivity that has seen the once heavily stereotyped and criticized class of drugs gaining widespread attention; in the United States, this is markedly bipartisan. At the center of this veritable renaissance, working alongside researchers, are organizations like Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF), a biotechnology company aiming to transform the treatment of mental health and addiction disorders.
Mydecine is playing a crucial role in advancing the knowledge of the benefits of psychedelics by developing innovative first and second-generation novel compounds for the treatment of mental health and addiction and sequentially collaborating with academics to undertake vital clinical research on them (https://ibn.fm/k8G8G).
So far, Mydecine has partnered with Johns Hopkins University to launch a seamless phase 2/3 clinical trial utilizing psilocybin for smoking cessation. Led by Principal Investigator Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University, the trial will evaluate the safety and efficacy of psilocybin-assisted psychotherapy using Mydecine’s lead drug candidate, MYCO-001, to treat tobacco addiction. Earlier this month, Mydecine submitted a pre-investigational new drug briefing package to the FDA for the trial (https://ibn.fm/OjsfH).
The company also intends to supply MYCO-001 in a planned multi-site smoking cessation trial led by Dr. Johnson and funded via a grant from the National Institute on Drug Abuse (“NIDA”) and is planning a separate Phase 2A trial focusing on PTSD in veterans. To this end, Mydecine recently announced Combat Stress, a leading UK-based charity aiding veterans’ mental health, as one of multiple sites for their upcoming clinical trials.
Additionally, Mydecine has partnered with Calgary-based Newly Institute Inc. to co-develop protocols and therapy manuals for different indications under their Special Access Support and Supply Program (“SASSP”) with the aim of expanding responsible, early-stage psychedelic-assisted therapy to patients (https://ibn.fm/bnmdH). And in a recent interview with Shadd Dales of The Dales Report, Mydecine CEO Josh Bartch stated that the company is looking to announce other similar partnerships in the coming weeks and months, specifically targeting large physician, therapy, and hospital networks (https://ibn.fm/ek2Yq).
Bartch also emphasized the need to assuage those who are still wary of psychedelics, noting that for the majority of the population to trust psychedelics, the general medical community has to have adopted this class of drugs as well as integrated it into the regular medical conversation. This, according to Bartch, will require education as well as the portrayal and communication of data “in the right way to that mental health medical community.” And though it may take a long time to accomplish, “it’s definitely going to happen, and it’s possible through consistent messaging throughout the industry,” Bartch concluded.
Valued at $3.21 billion in 2021, the psychedelic drug market is expected to reach $6.33 billion by 2026 (a 14.5% CAGR), buoyed by increased adoption of the drugs due to a large unmet need in the mental health segment (https://ibn.fm/y8KR0).
For more information, visit the company’s website at www.Mydecine.com.
NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF
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