• Novel drug development company Mydecine Innovations Group is focusing on a medicinal pipeline for psychedelic drug candidates that have established some efficacy in treating mental illnesses — specifically addiction
• Mydecine is progressing in its clinical trial evaluation of its lead candidate, MYCO-001, and is finalizing an IND application with the FDA to begin patient dosing for its planned Phase 2 trials
• The company is targeting nicotine addiction in tobacco smokers
• Mydecine is also advancing its evaluation of other drug candidates with pending patents to enhance its existing products

Medical-use psychedelic drug product developer Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) is making gains in its efforts to bring novel products to clinical trial for the potential treatment of addictive behaviors such as unhealthful smoking of tobacco-derived nicotine, announcing March 24 that an Institutional Review Board (“IRB”) has granted conditional approval for a new smoking cessation trial planned this summer (https://ibn.fm/43cgH).

Mydecine plans to begin patient recruitment in a multi-site Phase 2b clinical trial of its lead drug candidate MYCO-001, 99% pure psilocybin, once investigational new drug (“IND”) approval has been granted by the U.S. Food and Drug Administration (“FDA”). MYCO-001 would be used as a therapeutic, in conjunction with therapy, for nicotine-dependent individuals in partnership with Dr. Matthew Johnson of Johns Hopkins University, who will oversee the psychotherapy regimen.

The planned placebo-controlled study is designed to evaluate the safety and efficacy of psilocybin-assisted psychotherapy utilizing MYCO-001, building on prior smoking cessation studies Johnson and his team conducted that showed 59% of participants who received psychedelic-assisted therapy remained abstinent from smoking at 12 months, compared to 28% of patients who received a transdermal nicotine patch, according to the company (https://ibn.fm/RE3nq).

According to the Centers for Disease Control and Prevention (“CDC”), about 12.5% of the nation’s adult population currently smoked cigarettes as of 2020, amounting to about 30.8 million adults, 16 million of whom live with a smoking-related disease (https://ibn.fm/8S09q).

Mydecine representatives met with the FDA last month, and are preparing their finalized IND application as well as a request for Breakthrough Therapy designation that would grant MYCO-001 the possibility of an accelerated approval process. The company plans to submit both applications in Q2 2022 and is hopeful that the FDA will green-light the effort within 30 days.

The IRB’s approval is a conditional ethical review finding that will allow Mydecine to proceed once it has the FDA’s positive reply to its IND filing.

“We are beyond excited to share the news of our conditional IRB approval,” CEO Josh Bartch stated in the company’s announcement (https://ibn.fm/dNVrU). “Upon the near-term clearance of our IND application, which is wholly owned by Mydecine, we will be the first commercial IND approved utilizing psilocybin for the indication of smoking cessation, and one of a small number of organizations with a commercial FDA IND approval, alongside COMPASS Pathways, MindMed, and Usona, for a Phase 2 or later stage study assessing a psychedelic compound for any indication. We have a strong patent and regulatory strategy to support this initiative as well as further subsequent approvals.”

The Phase 2b study is contemplating a primary endpoint of six months, indicating it could publish data as early as Q4 2023, according to the company.

“Mydecine is currently working our second-generation drugs through the clinical pipeline to replace our first generation with a more superior, more refined, more scalable second generation of psychedelic medicine,” Bartch said in a video presentation the company posted to YouTube last month (https://ibn.fm/ADxjy). “We’re looking at known efficacious MYCO-001 single molecule psilocybin that we feel is drastically better than what’s currently available on the marketplace (for treating smoking cessation).”

The basis for the drug has already been established in nature, Chief Scientific Officer Rob Roscow said in the video.

“Mydecine takes a very nuanced approach to drug development,” Roscow said. “As opposed to designing molecules from scratch that may or may not affect a condition of interest, we’re taking molecules from nature, such as psilocybin, that have already shown strong efficaciousness in the conditions that they’re treating or being studied in treating, and then we’re making very purposeful modifications — changes or improvements to these. By building off of the templates that are provided by nature to us, we really can be confident of the value of these molecules moving further in the pipeline.”

The research-based company is also working to develop and commercialize other drug candidates, such as a patch-delivered tryptamine compound known as MYCO-004 and compounds MYCO-005 and MYCO-006 that target increased safety and stability in their respective psilocin and MDMA (Ecstasy) analogs, according to an investor presentation prepared by the company (https://ibn.fm/o7Bpl).

“These molecules include enhancements we believe are critical for psychedelic medicine to become accepted and adopted into traditional medical settings,” a March 7 management statement regarding MYCO-005 added (https://ibn.fm/de821). “MYCO-005 includes a novel psilocin analog that could potentially be considered a heart-safe microdose drug by eliminating a possible known risk factor. Although microdosing has been gaining popularity in mainstream media as a possible treatment for indications such as ADHD, depression and anxiety, more research is needed to confirm the safety and efficacy of this method. We believe our MYCO-005 family of molecules are safer than what’s currently available.”

A new subscription agreement for the sale of additional investor shares announced March 18 is designed to provide the company with “enhanced flexibility and access to capital should future additional financing be required, and it may be activated if and as deemed appropriate,” according to the company (https://ibn.fm/F0TEl).

For more information on Mydecine Innovations Group, 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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