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Saturday, October 1, 2022

Next Psychedelic Wave Builds As Data And Trial Results Set To Roll In




It’s been more than 18 months since Fortune magazine declared “psychedelic drugs may revolutionize mental healthcare.

Fortune pointed out how “Silicon Valley legends” and “billionaire financiers” were the main drivers of a resurgent interest in psychedelic drugs as treatments.

Since then, the race has ramped up massively with $100 million+ IPO’s, billion-dollar valuations, and the development of dozens of potential psychedelic-based treatments for PTSD, alcoholism, addiction, eating disorders, suicidal ideation, and more.

The race to unlock the potential of psychedelics as effective treatments is set to reach its next stage in the months ahead and investors are eyeing catalysts for psychedelic sector stocks.

Psychedelics are basically biotech stocks at this point and the largest catalyst is set to be the results from clinical trials.

That’s where the year ahead is set to be a big one for major psychedelics investors and backers.

In How ecstasy and psilocybin are shaking up psychiatry, published in the science Journal Nature, researchers found staggering growth in the studies of psychedelic drugs for medical purposes.

For example, from 2010 to 2018 there was an average of just four trials per year conducted focusing on the efficacy of either Psilocybin, MDMA, or LSD.

The number of psychedelic drug treatment studies beginning in 2019 soared to 12 and last year it rose again to 17 new studies.

The impact of the growing scope, scale, and number of these studies is set to hit the psychedelics sector in 2022.

One company that recently provided updates on its psychedelics studies is Mind Cure Health (MINDCURE) (CSE:MCUR) (OTC:MCURF).

MINDCURE is a life sciences company and an early mover in the psychedelic drug treatment development race.

One of its focuses has been on ibogaine, a psychedelic compound currently being researched as a treatment for many mental health conditions, including drug addiction.

MINDCURE recently announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the company applied for patents on two routes to the full chemical synthesis and initiated the scale up to produce Good Laboratory Practice (“GLP”) ibogaine leading to the Good Manufacturing Practice production for global supply of fully synthetic ibogaine. MINDCURE is on track and expects to have GLP supply available for research partners beginning in Q2 of 2022.

MINDCURE is also advancing MDMA, a common psychedelic which has been used by an estimated 17 million Americans, as part of a potential treatment for female Hypoactive Sexual Desire Disorder(HSDD).

The company’s research has identified a sizeable potential market HSDD treatment with an estimated 40% of U.S. women having self-reported low sexual desire and diagnosed HSDD affecting 10% of adult women and 14% of premenopausal adult women.

MINDCURE recently announced the next stage of this HSDD treatment development effort by

planning a pre-IND meeting with the FDA in Q1 of 2022, which would put the company on pace for launching a complete Phase 2 trial for the study of MDMA as a treatment HSDD to begin by the third quarter of 2022.

Kelsey Ramsden, President & Chief Executive Officer of MINDCURE says:

“We are proud to report that MINDCURE’s core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE’s drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline.”

READ THEIR FULL RELEASE HERE:

 

Other developments for the leading companies playing a role in the growth, acceptance, and development of the rapidly rising psychedelics sector:

MINDCURE (CSE:MCUR) (OTC:MCURF):

MINDCURE is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health.

The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally.

The company has several new developments in new research studies and has announced other major milestones it will be reaching in the months ahead.

It also recently announced it has maintained a large cash position of more than C$15 million as of August 31, 2021.

Cybin Inc (NEO:CYBN) (NYSE:CYBN):

Cybin is a life-sciences company focused on advancing psychedelic and nutraceutical-based products. 

It is also directly supporting clinical studies across North America and other regions through strategic academic and institutional partnerships.

Cybin recently announced that U.S. FDA has authorized an investigational new drug (IND) application to proceed with Cybin-sponsored feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

Dr. Alex Belser, Cybin’s chief clinical officer, stated, “The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’ — the ability to dynamically trace the neural correlates of human conscious experience. Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding.”

Cybin has met all the requirements and has successfully listed on and now trades on the NYSE in addition to Canada’s NEO Exchange.

Read the latest update from Cybin here: https://www.cybin.com/press-release/cybin-announces-fda-investigational-new-drug-authorization-of-cybins-sponsored-feasibility-study-using-kernel-flow-technology

Numinus Wellness (TSXV:NUMI) (OTC:LKYSF):

Numinus is developer of evidence-based psychedelic-assisted therapies.

The Numinus model — including psychedelic production, research and clinic care – targets healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use.

Numinus is leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Numinus recently announced the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract has been finalized.

This step is a major milestone that allows Numinus to advance its investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology submitted to the United States Patent and Trade Office.

Numinus has also successfully developed a natural extract, Psybina, from psilocybe species using IP (intellectual property) technology related to the production of extracts and downstream derivatives and formulations from psychoactive species cultured mycelium.

Read the latest from Numinus here: https://www.investors.numinus.com/news/news-details/2021/Numinus-Advances-Phase-1-Trial-on-Proprietary-Psilocybin-Product/default.aspx

ATAI Life Sciences (NASDAQ:ATAI):

ATAI Life Sciences describes itself as “a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.”

ATAI was originally founded in 2018 to address the chronic lack of innovation in the mental health treatment area.

It is targeting the developing therapies that were have been overlooked or underused, including those that involve use pf psychedelic compounds and digital therapeutics.

ATAI went public in June of 2021 and raised more than $200 to fund the company’s research efforts.

COMPASS Pathways (NASDAQ: CMPS):

COMPASS Pathways has emerged as one of the early leaders in the psychedelics sector. 

COMPASS describes itself as a “mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health.”

The company’s initial research is into how psilocybin therapy can help sufferers of treatment-resistant depression.

The research is currently in FDA Phase IIb study of 216 patients with treatment-resistant depression in 21 sites across Europe and North America.

COMPASS went public in September of 2020 when it raised more than $120 million as part of an initial public offering. 

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