- Mydecine has summitted a pre-IND briefing package to the FDA in readiness for its phase 2/3 smoking cessation trial scheduled for Q2 2022
- The study will be led by Dr. Matthew Johnson, with the placebo-controlled research being conducted at Johns Hopkins University
- Mydecine also announced its partnership with Combat Stress to use psilocybin in a psychoactive-assisted psychotherapy PTSD treatment program for veterans
- Combat Stress will also be one of several sites for the company’s upcoming clinical trials set to launch later in the year
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) plans to launch its seamless phase 2/3 smoking cessation clinical trial in the second quarter (“Q2”) of the 2022 financial year, with primary endpoints of three and six months. The study will build previous research conducted by Dr. Matthew Johnson, Ph.D., and his team at Johns Hopkins University. Their ongoing study is showing 59% of participants who received psychedelic-assisted therapy remained abstinent from smoking at 12 months. In comparison, only 28% of patients who received the transdermal nicotine patch remained abstinent (https://ibn.fm/KvEUG).
In readiness for the trial, Mydecine has submitted a pre-Investigational New Drug (“IND”) briefing package to the United States Food and Drug Administration (“FDA”). The submission will allow the company to evaluate its lead drug candidate, MYCO-001, in a structured smoking cessation treatment program, aiming to introduce the product in the market as early as 2024.
“We are excited to move forward on this important study, and our team has been working diligently to ensure that our pre-IND package is complete,” noted Josh Bartch, the Chief executive Officer (“CEO”) of Mydecine.
“As the only company currently investigating a psilocybin compound for smoking cessation, Mydecine is proud to be at the forefront of this research,” he added.
Dr. Johnson, a Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University (“JHU”), will be the Principal Investigator in this clinical study. The planned placebo-controlled study will be conducted at JHU, and the research will feature a combined phase that will utilize results acquired throughout the trial to adjust the course of the study.
According to the Centers for Disease Control and Prevention (“CDC”), in the United States alone, cigarette smoking is responsible for one out of every five deaths, representing an estimated 480,000 deaths every year. With about 34.1 million Americans smoking cigarettes, there is a growing need for smoking cessation alternatives, an opportunity that Mydecine is looking to tap into.
“Tobacco use is the greatest single, preventable cause of death in the world, yet there are few safe and effective treatments for nicotine addiction,” noted Mr. Bartch.
“With safety and efficacy concerns about current therapies, including the recall of the blockbuster treatment Chantix, there is a strong need for innovative and improved treatment options,” acknowledged Dr. Rakesh Jetly, the Chief Medical Officer (“CMO”) at Mydecine.
The pre-IND briefing package submission edges Mydecine closer to launching its MYCO-001 to the market. It is a tremendous milestone for the company and shows great promise for smoking cessation treatments.
In addition to smoking cessation, Mydecine is also exploring the use of psilocybin in treating Post-Traumatic Stress Disorder (“PTSD”). In what marks another significant move for the company, it just entered into a partnership with Combat Stress to use psilocybin in a psychedelic-assisted psychotherapy PTSD treatment program for veterans (https://ibn.fm/Gp3u9).
The company further confirmed that Combat Stress, one of the leading charities in the United Kingdom working with veterans, will be one of the several sites for its upcoming clinical trials, set to launch later in the year. The study will be led by Professor Dominic Murphy, the Head of Research at Combat Stress and the UK Psychological Trauma Society’s president.
“I am truly excited to be leading this study at Combat Stress,” noted Professor Murphy.
“This collaboration offers great potential for research focused on new, innovative therapeutics that offer significant opportunities to bring hope to those veterans still living with the trauma of their military experiences,” he added.
Data collected from this study will be integral to Mydecine advancing its drug development pipeline, coupled with its ability to bring a much-needed novel treatment to market. The company is also confident that there are more opportunities to expand its clinical trials and deliver on its mission to come up with safe and effective alternative medicine that people can trust with this partnership.
“There is a big unmet need when it comes to treating PTSD and other mental health conditions, especially within the veteran population, and this partnership demonstrates the strong progress we continue to make in bringing psychedelic-assisted psychotherapies to the forefront of the market and bring hope for all those struggling with these conditions,” reckoned Mr. Bartch.
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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