Palm Beach, FL – April 28, 2021 – Psychedelic medicine is having a moment. Once dismissed as a “party drug” for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression. For most, psychedelic drugs conjure up images of the 1960’s, hippies tripping out on LSD or magic mushrooms. However, early studies are finding that psilocybin – the active agent in magic mushrooms – could treat addiction, depression, anxiety and mental health conditions like post-traumatic stress disorder (PTSD). Similarly, cancer patients with painful anxiety over their illness have found more peaceful acceptance after participating in a study that involved intensive therapy and being given a drug that was once a symbol of the 60’s counterculture.  Last year, the US Food and Drug Administration (FDA) approved esketamine to treat depression, making it the first-ever psychedelic drug to receive the regulatory green light in the US, with UK authorities also giving their approval for the ketamine-like drug a few months later. Active companies in the markets this week include: COMPASS Pathways plc (NASDAQ: CMPS), Silo Pharma, Inc. (OTCQB: SILO), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Red Light Holland Corp. (OTCPK: TRUFF) (CSE: TRIP), Champignon Brands Inc. (OTCQB: SHRMF) (CSE: SHRM).

MDMA, commonly known as ecstasy meanwhile, has been given breakthrough therapy designation by the US regulator for post-traumatic stress disorder (PTSD). Against this backdrop, a flourishing new sub-sector of the life sciences industry is emerging. While there are many parallels with the development of the cannabis industry, the trailblazers in the field of psychedelics are keen to stress the differences, particularly with reference to the recreational element of the former.  An article in Proactive Investors said that: “Psychedelics weren’t born of the counterculture. They were killed by it,” says a report by investment bank Canaccord Genuity, authored by Tania Gonsalves and Scott McFarland, which provides some of the first in-depth analysis of the sector.”

Silo Pharma, Inc. (OTCQB: SILO) BREAKING NEWS:  Silo Pharma (SILO) and Zylo Therapeutics, Inc. (ZTI) enter into Joint Venture Agreement to focus on the clinical development of ketamine using ZTI’s Z-pod technology for the transdermal time released delivery of therapeutics – Silo Pharma, Inc., a developmental stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announced that it has entered into a Joint Venture with Zylo Therapeutics. This Joint Venture will utilize Zylo’s innovative sustained release topical delivery system that was originally developed at Albert Einstein College of Medicine using Silo Pharma’s expertise in the use of psychedelics. The joint venture will initially explore the clinical development of ketamine using ZTI’s Z-pod technology, but also provides for Silo Pharma to obtain an exclusive option for the clinical development of psilocybin using ZTI’s Z-pod technology as well.

Eric Weisblum, CEO of Silo Pharma stated “This Joint Venture is part of Silo Pharma’s vision of bringing ground breaking therapeutics to patients in need. The ability to deliver Ketamine or Psilocybin in a time released manner will allow us to explore both the safety and efficacy of our therapeutics while hopefully diminishing the hallucinogenic effects of psychedelics. We believe that Zylo’s patented technology will allow us to reach potential patients that suffer with dysphagia, such as both Alzheimer’s and Parkinson’s patients.”

Jay Blankenship, MD , Vice President of Business Development for Zylö Therapeutics, stated “We are extremely excited to be entering into this partnership with Silo Pharma, a company with broad-ranging expertise in psychedelics. Ketamine is an incredibly versatile drug that continues to show promise with new therapeutic indications. We look forward to leveraging our proprietary topical delivery technology to develop a low-dose, sustained-release ketamine formulation that is both safe and convenient for patients.”  For more information, visit www.silopharma.com

FOR MORE INFORMATION ABOUT THE INDUSTRY AND SILO, PLEASE ALSO VISIT:  https://psychedelicstox.com/2021/04/26/unique-double-play-biotech-company-offers-investors-true-upside-potential-in-the-psychedelic-space/

Other recent developments in the markets include:

MindMed (NASDAQ: MNMD) (NEO: MMED), a leading clinical-stage psychedelic medicine biotech company, recently announced the publication of the first study on MDMA dosing optimization using personalized medicine. The study took place at the University Hospital Basel Liechti Lab, in Basel, Switzerland. This study provides the first scientific data for predicting responses to MDMA and optimizing dosing. This may maximize the potential beneficial therapeutic effects while reducing adverse responses when treating medical conditions.  The study used data from 194 MDMA administrations in ten randomized placebo-controlled studies in healthy subjects conducted by the Liechti Lab at the University Hospital Basel, Switzerland.

Key findings of the study suggest: The dose of MDMA can be optimized using predictors known before dosing including body weight, sex, age, genetics, personality trait measures, and mood before drug administration; The dose of MDMA per kg body weight of the treated person best predicted the MDMA concentrations in the body and also mainly determined the acute subjective response to MDMA; Additionally, genetic testing of the drug metabolizing enzyme CYP2D6 is useful to adjust the dose of MDMA; Persons with low levels of CYP2D6 activity have higher MDMA plasma concentrations and may experience greater subjective MDMA effects and may benefit from a moderate dose reduction; Persons with a greater personality trait of “openness to a new experience” showed greater feelings of closeness and positive drug effects acutely induced by MDMA; In contrast, persons with personality traits of increased neuroticism or anxiety were both more likely to experience fear of ego dissolution and losing control. Similarly, more feelings of anxiety and depression in a person just before MDMA administration predicted more anxiety after MDMA administration; Women and men showed comparable MDMA effects if differences in body weight are considered in the dosing of MDMA; Previous minimal MDMA use, defined as previously using MDMA up to five times, did not influence the MDMA effect; and In summary, personalizing MDMA dosing may help optimize the acute MDMA experience including more positive subjective effects of MDMA and reducing adverse effects of MDMA.

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed a study published in the New England Journal of Medicine (NEJM) yesterday, which showed signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram, for major depressive disorder (MDD).

The study was designed and conducted by a research team at Imperial College London, using COMPASS’s COMP360 psilocybin.  This was an exploratory, randomized, double-blind clinical study. Its aim was to compare the efficacy and mechanisms of action of psilocybin with a six-week course of escitalopram, a selective serotonin reuptake inhibitor (SSRI), for MDD.

Halo Collective Inc. (“Halo”) and Red Light Holland Corp. (CSE: TRIP) (OTC Pink: TRUFF) (“Red Light Holland“) recently announced that Articles of Incorporation have been filed with the Oregon Secretary of State to form Red Light Oregon, Inc., a 50/50 JV between Halo and Red Light Holland. The JV will be capitalized with US$50,000 from each party and its initial directors will be Todd Shapiro, Red Light Holland Director and CEO, Sarah Hashkes, Red Light Holland Chief Technology and Innovation Officer, Kiran Sidhu, Halo CEO and Director, and Katie Field, Halo President. The JV will monitor ongoing regulatory updates regarding Oregon’s Measure 109, appoint a management team, and develop a commercialization strategy in due course.

“We are delighted to take this next step with Halo. We now have the entity and team in place to begin laying the groundwork for potential future participation in the Oregon Psychedelic Magic Mushroom market,” said Todd Shapiro, CEO and Director of Red Light Holland. “Kiran and his team have extensive experience working with Oregon regulators and we could not be more excited to have them as a partner! We also plan on continually monitoring other future markets opening in the USA as the movement, both socially and from a therapeutic/medicinal level promoting the acceptance of psilocybin via legal, policy and regulatory measures rapidly progresses.”

Champignon Brands Inc. (CSE: SHRM) (OTCQB: SHRMF) recently announced the publication of an article led by Dr. Roger McIntyre, CEO of Champignon Brands Inc. The article – The Rapid Mood Screener (RMS): a novel and pragmatic screener for bipolar I disorder – is published in Taylor and Francis.com.

Depressive episodes and symptoms of bipolar I disorder are commonly misdiagnosed as major depressive disorder (MDD) in primary care. The novel and pragmatic Rapid Mood Screener (RMS) was developed to screen for manic symptoms and bipolar I disorder features (e.g., age of depression onset) to address this unmet clinical need.

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