Mydecine Announces New Clinical Trial For Smoking Cessation

This article was originally published on Microdose and appears here with permission.

Following up on its recent announcement of a 5-year partnership with the prestigious research institute at Johns Hopkins University, and its positive Q2 financial results and business update, Mydecine Innovations Group MYCOF has made another major announcement.

In breaking news, Mydecine has just announced a Phase 2/3 clinical trial for smoking cessation for its MYCO-001 compound.

Mydecine to partner with John Hopkins in a groundbreaking trial

The trial will be a placebo-controlled study looking at the science and efficacy of Mydecine’s MYCO-001 for the treatment of nicotine dependence.

The study is projected to launch in Q1 2022, with results to be measured at three and six months. Despite this being an advanced phase that could normally take several years, this part of the trial could be completed as early as Q4 2022.

The study will be a collaboration with the Johns Hopkins psychedelic research group, run by Dr. Matthew Johnson, a world leader in the field with many published studies and research on the science of psychedelics. Dr. Johnson has been contracted by Mydecine to complete this phase 2/3 clinical trial, building on his current research on using psychedelics for smoking cessation.

Here’s some information from Mydecine’s press release on the results the current study is building on:

A 2014 Johns Hopkins University study published in the Journal of Psychopharmacology, showed an 80% abstinence rate at six months. Currently, the center is conducting a continuation on smoking cessation with a randomized comparative efficacy study involving 80 patients in which a transdermal nicotine patch and cognitive therapy treatment or psilocybin and cognitive therapy treatment are administered. Over half of the patients in the ongoing study have completed their 13-week program with compelling success rates that far exceed the 10% to 35% success rates for traditional smoking cessation therapies.

As principal Investigator, (Dr. Johnson) developed and published the first research on the psychedelic treatment of tobacco addiction in 2014. Dr. Johnson was the 2019 president of the Psychopharmacology and Substance Abuse Division of the American Psychological Association and is current president of the International Society for Research on Psychedelics, an organization he founded with colleagues.

If the early results are any indication, then we have reason to be quite optimistic for this study and future treatment of nicotine addiction.

An industry-first trial for a huge unmet market

If the trial goes ahead as planned this would be, as far as I can tell, the psychedelic medicine industry’s only clinical trial for quitting smoking. And it would be an advanced trial— already in Phase 2/3—putting it years ahead of anyone starting at preclinical or Phase 1 work.

Some interesting data from the press release:

• According to the Centers for Disease Control (CDC) and Prevention, cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year.
• Smoking is also directly associated with $1.4 trillion in health expenditures and productivity losses combined.
• Approximately 14% of the U.S. population, 34.1 million Americans, currently smoke cigarettes.
• In 2019, the global market for tobacco addiction was valued at $6 billion. By 2026, the market is expected to reach $64 billion, growing at a CAGR of 16.9%.
• Until it was recalled in July 2021, one of the most successful smoking cessations treatments was varenicline or Chantix. Sales for Chantix reached $1.1B in 2020 despite the potentially harmful side effects.

“As a physician who has worked with many patients struggling to quit highly addictive substances, I have seen firsthand the tremendous harm nicotine has on the body,” said Mydecine CMO Dr. Rakesh Jetly. “We are excited to be working alongside Johns Hopkins University toward safer and more effective treatments.”

From Mydecine CEO Josh Bartch “Current clinical data coming out of Johns Hopkins on the ongoing smoking cessation study is showing 12-month efficacy rates significantly higher than today’s gold standard with drastically increased safety profiles. We have been diligently working with the teams at Hopkins, Applied Pharmaceutical Innovation, The Weinberg Group, and ethica CRO to design the planned study.” Bartch continues, “We firmly believe in the high likelihood of receiving breakthrough therapy status on our MYCO-001 product for smoking cessation and look forward to updating the market soon on future developments.”

If Mydecine can roll out this trial as planned, and if the results follow those of Dr. Johnson’s previous study, then the company could have itself a serious first-mover’s advantage in a huge segment of the market.

We’ve been waiting to see if Mydecine can finally make the jump to that next level in the industry—let’s see if this trial is the spark that lights the fuse.